A Phase 1 interventional study of GSK2315698 (CPHPC) and GSK2398852 (unlabeled anti-SAP mAb) in Amyloidosis, sponsored by GlaxoSmithKline. Terminated at 1 site in Sweden. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Diagnostic
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Among 10 studies in Amyloidosis by GlaxoSmithKline — 1 open to participants now, 1 under way, none of them phase 3. Amyloidosis · GlaxoSmithKline.
Among the 10 studies in Amyloidosis by GlaxoSmithKline, this one is the 9th largest by enrollment, is one of 2 that started in 2018, is one of 7 in phase 1, and was the 8th registered.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
Browse Amyloidosis studies →1 of the 10 studies in Amyloidosis by GlaxoSmithKline is open now, in 3 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Australia, United Kingdom
Ages 18+
By country, each count listing its studies:
Of the 70 Amyloidosis studies recruiting now, 43 (61%) set no upper age limit and 3 (4%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 65 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 3 · Phase 3 1
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 46 across 189 interventional studies indexed under Amyloidosis.
Median enrollment 20 across the 10 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Amyloidosis by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.
Drug: GSK2315698 (CPHPC) · Drug: GSK2398852 (unlabeled anti-SAP mAb) · Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.
Drug: GSK2315698 (CPHPC) · Drug: GSK2398852 (unlabeled anti-SAP mAb) · Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.
Also known as: miridesap
Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.
Also known as: dezamizumab
89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.
Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852.
Time frame: Session 1: Days 4, 5, 6 and 8
Part A- Session 2: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented.
Time frame: Session 2: Days 3, 4 and 5
Part B: Peak SUV in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb
SUV in focal anatomical regions of the heart was planned to be measured.
Time frame: Days 3, 4 and 6
Part B: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV in focal anatomical regions of the heart was planned to be measured.
Time frame: Days 3, 4 and 6
Part A- Session 1: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.
Time frame: Session 1: Days 4, 5, 6 and 8
Part A- Session 2: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.
Time frame: Session 2: Days 3, 4 and 5
Part B: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb
SUV of whole heart was planned to be measured.
Time frame: Days 3, 4 and 6
Part B: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV of whole heart was planned to be measured.
Time frame: Days 3, 4 and 6
Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.
Time frame: Session 1: Days 4, 5, 6 and 8
Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyriod Gland-goitre Hotspot
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented.
Time frame: Session 1: Days 4 and 6
Part A- Session 2: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.
Time frame: Session 2: Days 3, 4 and 5
Part B: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb
SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.
Time frame: Days 3, 4 and 6
Part B: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.
Time frame: Days 3, 4 and 6
Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented.
Time frame: Session 1: Days 4, 5, 6 and 8
Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyroid Gland-goitre
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented.
Time frame: Session 1: Days 4 and 6
Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Testes
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented.
Time frame: Session 1: Days 4, 5 and 8
Part A- Session 2: Mean SUV of Total Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented.
Time frame: Session 2: Days 3, 4, and 5
Part B: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb
SUV of total radioactivity uptake for different organs/tissues was planned to be measured.
Time frame: Days 3, 4 and 6
Part B: Mean SUV of Total Radioactivity Uptake After an Anti-SAP mAb Dose Between 200 mg and <=500 mg
SUV of total radioactivity uptake for different organs/tissues was planned to be measured.
Time frame: Days 3, 4 and 6
Part A: Maximum Concentration in Plasma (Cmax) of Total mAb
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed.
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: Cmax of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A: Time Associated With Cmax (Tmax) of Total mAb
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: Tmax of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A: Clearance of Total mAb
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: Clearance of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A: Terminal Half-life (T1/2) of Total mAb
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: T1/2 of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A:Area Under the Concentration Time Curve Till Last Observation (AUC[0 to t]) of Total mAb
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: AUC(0 to t) of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A: Area Under the Concentration Time Curve Till Time Infinity (AUC[0 to Infinity]) of Total mAb
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
Time frame: Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7
Part B: AUC(0 to Infinity) of Total mAb
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
Time frame: Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8
Part A: Cmax of 89Zr-GSK2398852 PKs of Radioactivity (Radio-PK)
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
Time frame: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part B: Cmax of 89Zr-GSK2398852 Radio-PK
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
Time frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part A: Tmax of 89Zr- GSK2398852 Radio-PK
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
Time frame: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part B: Tmax of 89Zr-GSK2398852 Radio-PK
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
Time frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part A: T1/2 of 89Zr- GSK2398852 Radio-PK
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
Time frame: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part B: T1/2 of 89Zr- GSK2398852 Radio-PK
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
Time frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part A: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
Time frame: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part B: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
Time frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part A: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
Time frame: Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part B: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
Time frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6
Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.
Time frame: Up to Day 26
Part A: Number of Participants With Skin Rashes
Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: \<10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: \>30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Skin Rashes
Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: \<10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: \>30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).
Time frame: Up to Day 26
Part A: Number of Participants With Cardiac Adverse Events
The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Cardiac Adverse Events
The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported.
Time frame: Up to Day 26
Part A: Number of Participants With Infusion Related Reactions
Number of participants with any infusion related reactions are presented.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Infusion Related Reactions
Number of participants with any infusion related reactions were planned to be reported.
Time frame: Up to Day 26
Part A: Change From Baseline in Cardiac Troponin T and N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)
Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26; Session 2: Day 1- Pre-dose, Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26
Part B: Change From Baseline in Cardiac Troponin T and NT-ProBNP
Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline and up to Day 26
Part A: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal 12-lead ECG Findings
12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Inpatient Cardiac Telemetry
Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Inpatient Cardiac Telemetry
Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Outpatient Cardiac Telemetry
Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Outpatient Cardiac Telemetry
Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- \<90 and \>180 millimeters of mercury (mmHg), and DBP- \<30 and \>110 mmHg.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal SBP and DBP
SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Temperature
Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- \>37.5 degree celsius.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Temperature
Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Respiratory Rate
Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- \<12 and \>25 breaths per minute.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Respiratory Rate
Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
Time frame: Up to Day 26
Part A: Number of Participants With Abnormal Pulse Rate
Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- \<35 and \>140 beats per minute (bpm).
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Pulse Rate
Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
Time frame: Up to Day 26
Part A: Number of Participants With New Abnormal Physical Examination Findings
A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).
Time frame: Session 1: At screening (within 35 days of Anti-SAP treatment of session 1), Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11; Session 2: Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11
Part B: Number of Participants With New Abnormal Physical Examination Findings
A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).
Time frame: At screening (within 35 days of Anti-SAP treatment), Days 1, 3, 5, 8 and 11
Part A: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Blood samples were planned to be collected to analyze the hematology parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were planned to be collected to analyze the hematology parameter.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were planned to be collected to analyze the hematology parameter.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were planned to be collected to analyze the hematology parameter.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were planned to be collected to analyze the hematology parameter.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes
Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes
Blood samples were planned to be collected to analyze the hematology parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Chemistry Parameters: Albumin, Protein
Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Chemistry Parameters: Albumin, Protein
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)
Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Chemistry Parameters: ALP, ALT, AST
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine
Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26
Part B: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26
Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones
Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones.
Time frame: Up to Day 26 of the last session
Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen
Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen.
Time frame: Up to Day 26 of the last session
Part B: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones
Urine samples were planned to be collected to analyze the urinalysis parameters.
Time frame: Up to Day 26
Part B: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen
Urine samples were planned to be collected to analyze the urinalysis parameters.
Time frame: Up to Day 26
This was a two part study. Part A contains two dosing sessions and Part B contain single dosing session. This study was conducted at a single center in Sweden from 06-April-18 to 20-July-2018.
| Milestone | Part A: Anti-SAP | Part B: Anti-SAP |
|---|---|---|
| Started | 2 | 0 |
| Completed | 1 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Study closed/terminated | 1 | 0 |
| Milestone | Part A: Anti-SAP | Part B: Anti-SAP |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session1:Blood pool left atrium,Day4,n=2 | 2.995 ± 1.4637 |
| Session1:Blood pool left atrium,Day5,n=1 | 0.550 ± NA |
| Session1:Blood pool left atrium,Day6,n=1 | 0.640 ± NA |
| Session1:Blood pool left atrium,Day8,n=1 | 0.400 ± NA |
| Session1:Blood pool left ventricle,Day4,n=2 | 2.800 ± 1.5274 |
| Session1:Blood pool left ventricle,Day5,n=1 | 0.510 ± NA |
| Session1:Blood pool left ventricle,Day6,n=1 | 0.850 ± NA |
| Session1:Blood pool left ventricle,Day8,n=1 | 0.430 ± NA |
| Session1:Blood pool right ventricle,Day4,n=2 | 3.165 ± 1.1526 |
| Session1:Blood pool right ventricle,Day5,n=1 | 1.050 ± NA |
| Session1:Blood pool right ventricle,Day6,n=1 | 0.950 ± NA |
| Session1:Blood pool right ventricle,Day8,n=1 | 1.240 ± NA |
| Session1:Left ventricle wall-high uptake,Day4,n=2 | 2.380 ± 1.4425 |
| Session1:Left ventricle wall-high uptake,Day5,n=1 | 1.290 ± NA |
| Session1:Left ventricle wall-high uptake,Day6,n=1 | 3.400 ± NA |
| Session1:Left ventricle wall-high uptake,Day8,n=1 | 1.440 ± NA |
| Session1:Left ventricle wall-low uptake,Day4,n=2 | 1.740 ± 1.4425 |
| Session1:Left ventricle wall-low uptake,Day5,n=1 | 0.700 ± NA |
| Session1:Left ventricle wall-low uptake,Day6,n=1 | 1.840 ± NA |
| Session1:Left ventricle wall-low uptake,Day8,n=1 | 0.760 ± NA |
| Session1: Mid septum-high uptake,Day4,n=2 | 2.335 ± 1.2516 |
| Session1: Mid septum-high uptake,Day5,n=1 | 1.420 ± NA |
| Session1: Mid septum-high uptake,Day6,n=1 | 2.880 ± NA |
| Session1: Mid septum-high uptake,Day8,n=1 | 1.520 ± NA |
| Session1: Mid septum-low uptake,Day4,n=2 | 1.955 ± 1.6051 |
| Session1: Mid septum-low uptake,Day5,n=1 | 0.780 ± NA |
| Session1: Mid septum-low uptake,Day6,n=1 | 2.230 ± NA |
| Session1: Mid septum-low uptake,Day8,n=1 | 0.610 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 2 |
|---|---|
| Session2:Blood pool left atrium,Day3 | 10.290 ± NA |
| Session2:Blood pool left atrium,Day4 | 5.330 ± NA |
| Session2:Blood pool left atrium,Day5 | 3.550 ± NA |
| Session2:Blood pool left ventricle,Day3 | 10.120 ± NA |
| Session2:Blood pool left ventricle,Day4 | 4.910 ± NA |
| Session2:Blood pool left ventricle,Day5 | 3.110 ± NA |
| Session2:Blood pool right ventricle,Day3 | 10.390 ± NA |
| Session2:Blood pool right ventricle,Day4 | 5.160 ± NA |
| Session2:Blood pool right ventricle,Day5 | 3.500 ± NA |
| Session2:Left ventricle wall-high uptake,Day3 | 1.150 ± NA |
| Session2:Left ventricle wall-high uptake,Day4 | 4.540 ± NA |
| Session2: Left ventricle wall-high uptake,Day5 | 5.360 ± NA |
| Session2:Left ventricle wall-low uptake,Day3 | 3.110 ± NA |
| Session2:Left ventricle wall-low uptake,Day4 | 3.650 ± NA |
| Session2: Left ventricle wall-low uptake,Day5 | 3.980 ± NA |
| Session2: Mid septum-high uptake,Day3 | 4.680 ± NA |
| Session2: Mid septum-high uptake,Day4 | 4.200 ± NA |
| Session2: Mid septum-high uptake,Day5 | 4.780 ± NA |
| Session2: Mid septum-low uptake,Day3 | 3.580 ± NA |
| Session2: Mid septum-low uptake,Day4 | 3.570 ± NA |
| Session2: Mid septum-low uptake,Day5 | 3.800 ± NA |
SUV in focal anatomical regions of the heart was planned to be measured.
No measurements were reported for this outcome.
SUV in focal anatomical regions of the heart was planned to be measured.
No measurements were reported for this outcome.
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session 1: Day 4, n=2 | 2.470 ± 1.1738 |
| Session 1: Day 5, n=1 | 1.130 ± NA |
| Session 1: Day 6, n=1 | 1.320 ± NA |
| Session 1: Day 8, n=1 | 0.960 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.
| Grams per milliliter | Part A: Anti-SAP- Session 2 |
|---|---|
| Session 2: Day 3 | 7.090 ± NA |
| Session 2: Day 4 | 4.440 ± NA |
| Session 2: Day 5 | 3.390 ± NA |
SUV of whole heart was planned to be measured.
No measurements were reported for this outcome.
SUV of whole heart was planned to be measured.
No measurements were reported for this outcome.
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session1:Abdominal skin,Day 4,n=2 | 0.325 ± 0.2475 |
| Session1:Abdominal skin,Day 5,n=1 | 0.080 ± NA |
| Session1:Abdominal skin,Day 6,n=1 | 0.940 ± NA |
| Session1:Abdominal skin,Day 8,n=1 | 0.140 ± NA |
| Session1:Skin of the back,Day 4,n=2 | 0.125 ± 0.1061 |
| Session1:Skin of the back,Day 5,n=1 | 0.060 ± NA |
| Session1:Skin of the back,Day 6,n=1 | 0.230 ± NA |
| Session1:Skin of the back,Day 8,n=1 | 0.100 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session 1: Day 4 | 4.670 ± NA |
| Session 1: Day 6 | 4.240 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 2 |
|---|---|
| Session2:Thyroid gland-goitre hotspot,Day 3 | 1.890 ± NA |
| Session2:Thyroid gland-goitre hotspot,Day 4 | 3.690 ± NA |
| Session2:Thyroid gland-goitre hotspot,Day 5 | 3.190 ± NA |
| Session2:Abdominal skin,Day 3 | 0.620 ± NA |
| Session2:Abdominal skin,Day 4 | 0.780 ± NA |
| Session2:Abdominal skin,Day 5 | 0.870 ± NA |
| Session2:Skin of the back,Day 3 | 0.220 ± NA |
| Session2:Skin of the back,Day 4 | 0.250 ± NA |
| Session2:Skin of the back,Day 5 | 0.330 ± NA |
SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.
No measurements were reported for this outcome.
SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.
No measurements were reported for this outcome.
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session1:Adrenal gland,Day 4,n=2 | 11.665 ± 1.9304 |
| Session1:Adrenal gland,Day 5,n=1 | 10.770 ± NA |
| Session1:Adrenal gland,Day 6,n=1 | 12.020 ± NA |
| Session1:Adrenal gland,Day 8,n=1 | 10.900 ± NA |
| Session1: Aorta,Day 4,n=2 | 2.580 ± 1.3859 |
| Session1: Aorta,Day 5,n=1 | 0.360 ± NA |
| Session1: Aorta,Day 6,n=1 | 0.500 ± NA |
| Session1: Aorta,Day 8,n=1 | 0.650 ± NA |
| Session1: Bone marrow,Day 4,n=2 | 3.015 ± 0.7990 |
| Session1: Bone marrow,Day 5,n=1 | 3.170 ± NA |
| Session1: Bone marrow,Day 6,n=1 | 2.210 ± NA |
| Session1: Bone marrow,Day 8,n=1 | 3.880 ± NA |
| Session1: Kidney,Day 4,n=2 | 4.910 ± 1.1738 |
| Session1: Kidney,Day 5,n=1 | 5.130 ± NA |
| Session1: Kidney,Day 6,n=1 | 3.840 ± NA |
| Session1: Kidney,Day 8,n=1 | 4.820 ± NA |
| Session1:Liver,Day 4,n=2 | 17.805 ± 6.8519 |
| Session1:Liver,Day 5,n=1 | 25.560 ± NA |
| Session1:Liver,Day 6,n=1 | 16.940 ± NA |
| Session1:Liver,Day 8,n=1 | 24.800 ± NA |
| Session1: Spleen,Day 4,n=2 | 11.425 ± 2.2981 |
| Session1: Spleen,Day 5,n=1 | 11.050 ± NA |
| Session1: Spleen,Day 6,n=1 | 10.060 ± NA |
| Session1: Spleen,Day 8,n=1 | 11.340 ± NA |
| Session1:Abdominal region,Day 4,n=2 | 1.070 ± 0.5374 |
| Session1:Abdominal region,Day 5,n=1 | 0.610 ± NA |
| Session1:Abdominal region,Day 6,n=1 | 1.740 ± NA |
| Session1:Abdominal region,Day 8,n=1 | 0.460 ± NA |
| Session1: Brain,Day 4,n=2 | 0.125 ± 0.0354 |
| Session1: Brain,Day 5,n=1 | 0.060 ± NA |
| Session1: Brain,Day 6,n=1 | 0.070 ± NA |
| Session1: Brain,Day 8,n=1 | 0.070 ± NA |
| Session1: Lung,Day 4,n=2 | 0.555 ± 0.1202 |
| Session1: Lung,Day 5,n=1 | 0.440 ± NA |
| Session1: Lung,Day 6,n=1 | 0.260 ± NA |
| Session1: Lung,Day 8,n=1 | 0.400 ± NA |
| Session1:Parotid gland,Day 4,n=2 | 0.570 ± 0.2970 |
| Session1:Parotid gland,Day 5,n=1 | 0.240 ± NA |
| Session1:Parotid gland,Day 6,n=1 | 0.580 ± NA |
| Session1:Parotid gland,Day 8,n=1 | 0.170 ± NA |
| Session1: Thigh,Day 4,n=2 | 0.260 ± 0.1131 |
| Session1: Thigh,Day 5,n=1 | 0.110 ± NA |
| Session1: Thigh,Day 6,n=1 | 0.200 ± NA |
| Session1: Thigh,Day 8,n=1 | 0.110 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session1: Day 4 | 1.630 ± NA |
| Session1: Day 6 | 1.390 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 1 |
|---|---|
| Session1: Day 4 | 5.400 ± NA |
| Session1: Day 5 | 5.520 ± NA |
| Session1: Day 8 | 5.670 ± NA |
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented.
| Grams per milliliter | Part A: Anti-SAP- Session 2 |
|---|---|
| Session2: Adrenal gland,Day 3 | 4.800 ± NA |
| Session2: Adrenal gland,Day 4 | 8.380 ± NA |
| Session2: Adrenal gland,Day 5 | 6.360 ± NA |
| Session2: Aorta,Day 3 | 10.000 ± NA |
| Session2: Aorta,Day 4 | 5.890 ± NA |
| Session2: Aorta,Day 5 | 3.310 ± NA |
| Session2: Bone marrow,Day 3 | 1.860 ± NA |
| Session2: Bone marrow,Day 4 | 1.910 ± NA |
| Session2: Bone marrow,Day 5 | 1.410 ± NA |
| Session2: Kidney,Day 3 | 2.700 ± NA |
| Session2: Kidney,Day 4 | 3.260 ± NA |
| Session2: Kidney,Day 5 | 2.890 ± NA |
| Session2:Liver,Day 3 | 4.770 ± NA |
| Session2:Liver,Day 4 | 7.560 ± NA |
| Session2:Liver,Day 5 | 8.340 ± NA |
| Session2: Spleen,Day 3 | 4.440 ± NA |
| Session2: Spleen,Day 4 | 5.140 ± NA |
| Session2: Spleen,Day 5 | 5.440 ± NA |
| Session2:Abdominal region,Day 3 | 0.900 ± NA |
| Session2:Abdominal region,Day 4 | 2.170 ± NA |
| Session2:Abdominal region,Day 5 | 2.370 ± NA |
| Session2: Brain,Day 3 | 0.370 ± NA |
| Session2: Brain,Day 4 | 0.210 ± NA |
| Session2: Brain,Day 5 | 0.110 ± NA |
| Session2: Lung,Day 3 | 1.230 ± NA |
| Session2: Lung,Day 4 | 0.930 ± NA |
| Session2: Lung,Day 5 | 0.790 ± NA |
| Session2:Parotid gland,Day 3 | 1.550 ± NA |
| Session2:Parotid gland,Day 4 | 1.180 ± NA |
| Session2:Parotid gland,Day 5 | 0.850 ± NA |
| Session2: Thigh,Day 3 | 0.630 ± NA |
| Session2: Thigh,Day 4 | 0.530 ± NA |
| Session2: Thigh,Day 5 | 0.330 ± NA |
| Session2:Thyroid gland-goitre,Day 3 | 1.870 ± NA |
| Session2:Thyroid gland-goitre,Day 4 | 2.090 ± NA |
| Session2:Thyroid gland-goitre,Day 5 | 1.950 ± NA |
SUV of total radioactivity uptake for different organs/tissues was planned to be measured.
No measurements were reported for this outcome.
SUV of total radioactivity uptake for different organs/tissues was planned to be measured.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed.
| Nanograms per milliliter | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 18061.0 (7474 to 28648) |
| Session 2, n=1 | 226994.0 (226994 to 226994) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
| Hours | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 3.010 (1.02 to 5.00) |
| Session 2, n=1 | 6.100 (6.10 to 6.10) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
| Liters per hour | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | NA (NA to NA) |
| Session 2, n=1 | NA (NA to NA) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
| Hours | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 17.70 (13.5 to 21.9) |
| Session 2, n=1 | 23.10 (23.1 to 23.1) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
| Hours*nanogram per milliliter | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 471241.0 (173964 to 768518) |
| Session 2, n=1 | 8274231.0 (8274231 to 8274231) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).
| Hours*nanogram per milliliter | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 487420.5 (186190 to 788651) |
| Session 2, n=1 | 8696309.0 (8696309 to 8696309) |
Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
| Becquerel per gram | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 9240.5 (6599 to 11882) |
| Session 2, n=1 | 11923.0 (11923 to 11923) |
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
| Hours | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 1.160 (1.15 to 1.17) |
| Session 2, n=1 | 1.100 (1.10 to 1.10) |
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
| Hours | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 14.50 (13.8 to 15.2) |
| Session 2, n=1 | 26.70 (26.7 to 26.7) |
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
| Hours*Becquerel per gram | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 168044.5 (92052 to 244037) |
| Session 2, n=1 | 386077.0 (386077 to 386077) |
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.
| Hours*Becquerel per gram | Part A: Anti-SAP |
|---|---|
| Session 1, n=2 | 174764.0 (96432 to 253096) |
| Session 2, n=1 | 457666.0 (457666 to 457666) |
Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852.
| Participants | Part A: Anti-SAP |
|---|---|
| AEs | 2 |
| SAEs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.
No measurements were reported for this outcome.
Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: \<10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: \>30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).
| Participants | Part A: Anti-SAP |
|---|---|
| Grade 1 | 0 |
| Grade 2 | 1 |
| Grade 3 | 0 |
| Grade 4 | 0 |
Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: \<10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: \>30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).
No measurements were reported for this outcome.
The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Cardiac Adverse Events | 0 |
The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported.
No measurements were reported for this outcome.
Number of participants with any infusion related reactions are presented.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Infusion Related Reactions | 0 |
Number of participants with any infusion related reactions were planned to be reported.
No measurements were reported for this outcome.
Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Nanograms per liter | Part A: Anti-SAP |
|---|---|
| Troponin T:Session1-Day2,n=2 | -6.45 ± 5.020 |
| Troponin T:Session1-Day3,n=2 | -13.15 ± 13.930 |
| Troponin T:Session1-Day4,n=2 | 2.40 ± 5.091 |
| Troponin T:Session1-Day5,n=2 | -4.80 ± 3.111 |
| Troponin T:Session1-Day6,n=2 | 0.80 ± 4.525 |
| Troponin T:Session1-Day7,n=2 | -4.85 ± 3.041 |
| Troponin T:Session1-Day8,n=2 | -1.45 ± 0.636 |
| Troponin T:Session1-Day9,n=2 | -4.65 ± 3.323 |
| Troponin T:Session1-Day10,n=2 | 17.00 ± 26.870 |
| Troponin T:Session1-Day26,n=2 | -5.45 ± 5.020 |
| Troponin T:Session2-Day1-pre-dose,n=1 | -2.10 ± NA |
| Troponin T:Session2-Day2,n=1 | -4.40 ± NA |
| Troponin T:Session2-Day3,n=1 | -2.80 ± NA |
| Troponin T:Session2-Day4,n=1 | -2.90 ± NA |
| Troponin T:Session2-Day5,n=1 | -3.00 ± NA |
| Troponin T:Session2-Day6,n=1 | -3.70 ± NA |
| Troponin T:Session2-Day7,n=1 | -2.20 ± NA |
| Troponin T:Session2-Day8,n=1 | -3.30 ± NA |
| Troponin T:Session2-Day9,n=1 | -2.60 ± NA |
| Troponin T:Session2-Day10,n=1 | -2.00 ± NA |
| Troponin T:Session2-Day26,n=1 | -3.60 ± NA |
| NT-ProBNP:Session1-Day2,n=2 | -525.0 ± 530.33 |
| NT-ProBNP:Session1-Day3,n=2 | -525.0 ± 502.05 |
| NT-ProBNP:Session1-Day4,n=2 | 835.0 ± 601.04 |
| NT-ProBNP:Session1-Day5,n=2 | -35.0 ± 7.07 |
| NT-ProBNP:Session1-Day6,n=2 | 360.0 ± 1004.09 |
| NT-ProBNP:Session1-Day7,n=2 | 470.0 ± 636.40 |
| NT-ProBNP:Session1-Day8,n=2 | 540.0 ± 579.83 |
| NT-ProBNP:Session1-Day9,n=2 | -90.0 ± 381.84 |
| NT-ProBNP:Session1-Day10,n=2 | 585.0 ± 1124.30 |
| NT-ProBNP:Session1-Day26,n=2 | 115.0 ± 558.61 |
| NT-ProBNP:Session2-Day1-pre-dose,n=1 | 20.0 ± NA |
| NT-ProBNP:Session2-Day2,n=1 | -80.0 ± NA |
| NT-ProBNP:Session2-Day3,n=1 | -240.0 ± NA |
| NT-ProBNP:Session2-Day4,n=1 | 280.0 ± NA |
| NT-ProBNP:Session2-Day5,n=1 | 60.0 ± NA |
| NT-ProBNP:Session2-Day6,n=1 | 1040.0 ± NA |
| NT-ProBNP:Session2-Day7,n=1 | 1030.0 ± NA |
| NT-ProBNP:Session2-Day8,n=1 | 400.0 ± NA |
| NT-ProBNP:Session2-Day9,n=1 | 120.0 ± NA |
| NT-ProBNP:Session2-Day10,n=1 | -40.0 ± NA |
| NT-ProBNP:Session2-Day26,n=1 | 0.0 ± NA |
Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
No measurements were reported for this outcome.
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
| Participants | Part A: Anti-SAP |
|---|---|
| CS | 0 |
| NCS | 2 |
12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.
No measurements were reported for this outcome.
Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
| Participants | Part A: Anti-SAP |
|---|---|
| CS | 0 |
| NCS | 2 |
Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device.
No measurements were reported for this outcome.
Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
| Participants | Part A: Anti-SAP |
|---|---|
| CS | 0 |
| NCS | 2 |
Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device.
No measurements were reported for this outcome.
SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- \<90 and \>180 millimeters of mercury (mmHg), and DBP- \<30 and \>110 mmHg.
| Participants | Part A: Anti-SAP |
|---|---|
| SBP | 0 |
| DBP | 0 |
SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
No measurements were reported for this outcome.
Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- \>37.5 degree celsius.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Abnormal Temperature | 0 |
Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
No measurements were reported for this outcome.
Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- \<12 and \>25 breaths per minute.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Abnormal Respiratory Rate | 0 |
Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
No measurements were reported for this outcome.
Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- \<35 and \>140 beats per minute (bpm).
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Abnormal Pulse Rate | 0 |
Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.
No measurements were reported for this outcome.
A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).
| Participants | Part A: Anti-SAP |
|---|---|
| Session 1:Screening,n=2 | 1 |
| Session1:Day 1 Pre-dose,n=2 | 2 |
| Session1:Day 3,n=2 | 0 |
| Session 1:Day 5,n=2 | 1 |
| Session1:Day 8,n=2 | 0 |
| Session1:Day 11,n=2 | 0 |
| Session2:Day 1 Pre-dose,n=1 | 0 |
| Session2:Day 3,n=1 | 0 |
| Session2:Day 5,n=1 | 1 |
| Session2:Day 8,n=1 | 0 |
| Session2:Day 11,n=1 | 0 |
A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Billion cells per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Basophils, Day 3, n=2 | 0.000 ± 0.0141 |
| Session 1: Basophils, Day 5, n=2 | -0.010 ± 0.0000 |
| Session 1: Basophils, Day 7, n=2 | -0.015 ± 0.0071 |
| Session 1: Basophils, Day 10, n=2 | -0.015 ± 0.0071 |
| Session 1: Basophils, Day 26, n=2 | -0.005 ± 0.0071 |
| Session 2: Basophils, Day1-pre-dose, n=1 | -0.010 ± NA |
| Session 2: Basophils, Day 3, n=1 | -0.010 ± NA |
| Session 2: Basophils, Day 5, n=1 | -0.020 ± NA |
| Session 2: Basophils, Day 7, n=1 | -0.010 ± NA |
| Session 2: Basophils, Day 10, n=1 | 0.000 ± NA |
| Session 2: Basophils, Day 26, n=1 | -0.010 ± NA |
| Session 1: Eosinophils, Day 3, n=2 | -0.025 ± 0.3182 |
| Session 1: Eosinophils, Day 5, n=2 | 0.050 ± 0.2121 |
| Session 1: Eosinophils, Day 7, n=2 | 0.000 ± 0.1414 |
| Session 1: Eosinophils, Day 10, n=2 | 0.000 ± 0.1414 |
| Session 1: Eosinophils, Day 26, n=2 | 0.050 ± 0.3536 |
| Session 2: Eosinophils, Day1-pre-dose, n=1 | -0.100 ± NA |
| Session 2: Eosinophils, Day 3, n=1 | -0.100 ± NA |
| Session 2: Eosinophils, Day 5, n=1 | -0.200 ± NA |
| Session 2: Eosinophils, Day 7, n=1 | -0.100 ± NA |
| Session 2: Eosinophils, Day 10, n=1 | -0.100 ± NA |
| Session 2: Eosinophils, Day 26, n=1 | -0.230 ± NA |
| Session 1: Lymphocytes, Day 3, n=2 | -0.05 ± 0.636 |
| Session 1: Lymphocytes, Day 5, n=2 | 0.30 ± 0.141 |
| Session 1: Lymphocytes, Day 7, n=2 | 0.05 ± 0.212 |
| Session 1: Lymphocytes, Day 10, n=2 | -0.20 ± 0.424 |
| Session 1: Lymphocytes, Day 26, n=2 | -0.10 ± 0.849 |
| Session 2: Lymphocytes, Day1-pre-dose, n=1 | -0.30 ± NA |
| Session 2: Lymphocytes, Day 3, n=1 | -0.30 ± NA |
| Session 2: Lymphocytes, Day 5, n=1 | -0.20 ± NA |
| Session 2: Lymphocytes, Day 7, n=1 | 0.30 ± NA |
| Session 2: Lymphocytes, Day 10, n=1 | -0.40 ± NA |
| Session 2: Lymphocytes, Day 26, n=1 | -0.80 ± NA |
| Session 1: Monocytes, Day 3, n=2 | 0.15 ± 0.212 |
| Session 1: Monocytes, Day 5, n=2 | 0.10 ± 0.000 |
| Session 1: Monocytes, Day 7, n=2 | 0.15 ± 0.212 |
| Session 1: Monocytes, Day 10, n=2 | 0.15 ± 0.212 |
| Session 1: Monocytes, Day 26, n=2 | 0.20 ± 0.141 |
| Session 2: Monocytes, Day1-pre-dose, n=1 | 0.00 ± NA |
| Session 2: Monocytes, Day 3, n=1 | 0.00 ± NA |
| Session 2: Monocytes, Day 5, n=1 | 0.00 ± NA |
| Session 2: Monocytes, Day 7, n=1 | 0.00 ± NA |
| Session 2: Monocytes, Day 10, n=1 | 0.00 ± NA |
| Session 2: Monocytes, Day 26, n=1 | -0.10 ± NA |
| Session 1: Neutrophils, Day 3, n=2 | 0.20 ± 0.707 |
| Session 1: Neutrophils, Day 5, n=2 | 0.45 ± 1.202 |
| Session 1: Neutrophils, Day 7, n=2 | 0.00 ± 0.000 |
| Session 1: Neutrophils, Day 10, n=2 | -0.05 ± 0.212 |
| Session 1: Neutrophils, Day 26, n=2 | 0.05 ± 0.354 |
| Session 2: Neutrophils, Day1-pre-dose, n=1 | -0.70 ± NA |
| Session 2: Neutrophils, Day 3, n=1 | -1.20 ± NA |
| Session 2: Neutrophils, Day 5, n=1 | 0.00 ± NA |
| Session 2: Neutrophils, Day 7, n=1 | -0.70 ± NA |
| Session 2: Neutrophils, Day 10, n=1 | -1.00 ± NA |
| Session 2: Neutrophils, Day 26, n=1 | 0.40 ± NA |
| Session 1: Platelets, Day 3, n=2 | -7.5 ± 4.95 |
| Session 1: Platelets, Day 5, n=2 | -29.5 ± 23.33 |
| Session 1: Platelets, Day 7, n=2 | -21.0 ± 4.24 |
| Session 1: Platelets, Day 10, n=2 | -13.0 ± 1.41 |
| Session 1: Platelets, Day 26, n=2 | 12.0 ± 14.14 |
| Session 2: Platelets, Day1-pre-dose, n=1 | -5.0 ± NA |
| Session 2: Platelets, Day 3, n=1 | -32.0 ± NA |
| Session 2: Platelets, Day 5, n=1 | -27.0 ± NA |
| Session 2: Platelets, Day 7, n=1 | -31.0 ± NA |
| Session 2: Platelets, Day 10, n=1 | -33.0 ± NA |
| Session 2: Platelets, Day 26, n=1 | -9.0 ± NA |
Blood samples were planned to be collected to analyze the hematology parameters.
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Percentage of red blood cells in blood | Part A: Anti-SAP |
|---|---|
| Session 1: Day 3, n=2 | -0.015 ± 0.0071 |
| Session 1: Day 5, n=2 | -0.025 ± 0.0071 |
| Session 1: Day 7, n=2 | -0.010 ± 0.0283 |
| Session 1: Day 10, n=2 | -0.020 ± 0.0283 |
| Session 1: Day 26, n=2 | -0.015 ± 0.0212 |
| Session 2: Day1-pre-dose, n=1 | -0.040 ± NA |
| Session 2: Day 3, n=1 | -0.040 ± NA |
| Session 2: Day 5, n=1 | -0.040 ± NA |
| Session 2: Day 7, n=1 | -0.050 ± NA |
| Session 2: Day 10, n=1 | -0.040 ± NA |
| Session 2: Day 26, n=1 | -0.050 ± NA |
Blood samples were planned to be collected to analyze the hematology parameter.
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Grams per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Day 3, n=2 | -6.5 ± 2.12 |
| Session 1: Day 5, n=2 | -10.5 ± 3.54 |
| Session 1: Day 7, n=2 | -6.5 ± 3.54 |
| Session 1: Day 10, n=2 | -8.0 ± 5.66 |
| Session 1: Day 26, n=2 | -5.5 ± 2.12 |
| Session 2: Day1-pre-dose, n=1 | -9.0 ± NA |
| Session 2: Day 3, n=1 | -12.0 ± NA |
| Session 2: Day 5, n=1 | -11.0 ± NA |
| Session 2: Day 7, n=1 | -14.0 ± NA |
| Session 2: Day 10, n=1 | -15.0 ± NA |
| Session 2: Day 26, n=1 | -17.0 ± NA |
Blood samples were planned to be collected to analyze the hematology parameter.
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Picograms | Part A: Anti-SAP |
|---|---|
| Session 1: Day 3, n=2 | 0.0 ± 0.00 |
| Session 1: Day 5, n=2 | 0.0 ± 0.00 |
| Session 1: Day 7, n=2 | 0.0 ± 0.00 |
| Session 1: Day 10, n=2 | 0.5 ± 0.71 |
| Session 1: Day 26, n=2 | 0.5 ± 0.71 |
| Session 2: Day1-pre-dose, n=1 | 0.0 ± NA |
| Session 2: Day 3, n=1 | 0.0 ± NA |
| Session 2: Day 5, n=1 | 0.0 ± NA |
| Session 2: Day 7, n=1 | 1.0 ± NA |
| Session 2: Day 10, n=1 | 0.0 ± NA |
| Session 2: Day 26, n=1 | 0.0 ± NA |
Blood samples were planned to be collected to analyze the hematology parameter.
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Femtoliter | Part A: Anti-SAP |
|---|---|
| Session 1: Day 3, n=2 | 0.75 ± 1.485 |
| Session 1: Day 5, n=2 | 0.90 ± 0.707 |
| Session 1: Day 7, n=2 | 1.85 ± 4.455 |
| Session 1: Day 10, n=2 | 0.45 ± 1.061 |
| Session 1: Day 26, n=2 | 0.60 ± 1.556 |
| Session 2: Day1-pre-dose, n=1 | -2.60 ± NA |
| Session 2: Day 3, n=1 | -2.50 ± NA |
| Session 2: Day 5, n=1 | -3.10 ± NA |
| Session 2: Day 7, n=1 | -0.90 ± NA |
| Session 2: Day 10, n=1 | 1.50 ± NA |
| Session 2: Day 26, n=1 | -0.90 ± NA |
Blood samples were planned to be collected to analyze the hematology parameter.
No measurements were reported for this outcome.
Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| 10^12 cells per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Erythrocytes, Day 3, n=2 | -0.175 ± 0.0212 |
| Session 1: Erythrocytes, Day 5, n=2 | -0.295 ± 0.1485 |
| Session 1: Erythrocytes, Day 7, n=2 | -0.180 ± 0.1556 |
| Session 1: Erythrocytes, Day 10, n=2 | -0.230 ± 0.2687 |
| Session 1: Erythrocytes, Day 26, n=2 | -0.200 ± 0.1273 |
| Session 2: Erythrocytes, Day1-Pre-dose, n=1 | -0.270 ± NA |
| Session 2: Erythrocytes, Day 3, n=1 | -0.340 ± NA |
| Session 2: Erythrocytes, Day 5, n=1 | -0.290 ± NA |
| Session 2: Erythrocytes, Day 7, n=1 | -0.480 ± NA |
| Session 2: Erythrocytes, Day 10, n=1 | -0.480 ± NA |
| Session 2: Erythrocytes, Day 26, n=1 | -0.470 ± NA |
| Session 1: Reticulocytes, Day 3, n=2 | -0.0085 ± 0.00212 |
| Session 1: Reticulocytes, Day 5, n=2 | -0.0085 ± 0.00636 |
| Session 1: Reticulocytes, Day 7, n=2 | -0.0075 ± 0.00778 |
| Session 1: Reticulocytes, Day 10, n=2 | -0.0065 ± 0.00919 |
| Session 1: Reticulocytes, Day 26, n=2 | -0.0035 ± 0.01061 |
| Session 2: Reticulocytes, Day1-pre-dose, n=1 | -0.0100 ± NA |
| Session 2: Reticulocytes, Day 3, n=1 | -0.0180 ± NA |
| Session 2: Reticulocytes, Day 5, n=1 | -0.0140 ± NA |
| Session 2: Reticulocytes, Day 7, n=1 | -0.0100 ± NA |
| Session 2: Reticulocytes, Day 10, n=1 | -0.0170 ± NA |
| Session 2: Reticulocytes, Day 26, n=1 | -0.0030 ± NA |
Blood samples were planned to be collected to analyze the hematology parameters.
No measurements were reported for this outcome.
Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Millimoles per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Glucose, Day 3, n=2 | -2.40 ± 3.253 |
| Session 1: Glucose, Day 5, n=2 | -2.45 ± 4.455 |
| Session 1: Glucose, Day 7, n=2 | -3.25 ± 5.303 |
| Session 1: Glucose, Day 10, n=2 | -3.60 ± 2.404 |
| Session 1: Glucose, Day 26, n=2 | -2.60 ± 2.970 |
| Session 2: Glucose, Day1-pre-dose, n=1 | 1.10 ± NA |
| Session 2: Glucose, Day 3, n=1 | -1.80 ± NA |
| Session 2: Glucose, Day 5, n=1 | -1.70 ± NA |
| Session 2: Glucose, Day 7, n=1 | -2.30 ± NA |
| Session 2: Glucose, Day 10, n=1 | -1.80 ± NA |
| Session 2: Glucose, Day 26, n=1 | 0.30 ± NA |
| Session 1: Calcium, Day 3, n=2 | -0.050 ± 0.0141 |
| Session 1: Calcium, Day 5, n=2 | -0.075 ± 0.0354 |
| Session 1: Calcium, Day 7, n=1 | -0.090 ± NA |
| Session 1: Calcium, Day 10, n=2 | -0.010 ± 0.1556 |
| Session 1: Calcium, Day 26, n=2 | -0.030 ± 0.0424 |
| Session 2: Calcium, Day1-pre-dose, n=1 | 0.020 ± NA |
| Session 2: Calcium, Day 3, n=1 | -0.140 ± NA |
| Session 2: Calcium, Day 5, n=1 | -0.030 ± NA |
| Session 2: Calcium, Day 7, n=1 | -0.080 ± NA |
| Session 2: Calcium, Day 10, n=1 | -0.040 ± NA |
| Session 2: Calcium, Day 26, n=1 | 0.040 ± NA |
| Session 1: Potassium, Day 3, n=2 | -0.10 ± 0.141 |
| Session 1: Potassium, Day 5, n=2 | -0.10 ± 0.141 |
| Session 1: Potassium, Day 7, n=1 | 0.00 ± NA |
| Session 1: Potassium, Day 10, n=2 | -0.30 ± 0.141 |
| Session 1: Potassium, Day 26, n=2 | -0.30 ± 0.000 |
| Session 2: Potassium, Day1-pre-dose, n=1 | -0.10 ± NA |
| Session 2: Potassium, Day 3, n=1 | -0.50 ± NA |
| Session 2: Potassium, Day 5, n=1 | 0.10 ± NA |
| Session 2: Potassium, Day 7, n=1 | -0.50 ± NA |
| Session 2: Potassium, Day 10, n=1 | -0.40 ± NA |
| Session 2: Potassium, Day 26, n=1 | -0.10 ± NA |
| Session 1: Sodium, Day 3, n=2 | 3.0 ± 1.41 |
| Session 1: Sodium, Day 5, n=2 | -0.5 ± 0.71 |
| Session 1: Sodium, Day 7, n=2 | 2.0 ± 1.41 |
| Session 1: Sodium, Day 10, n=2 | 3.5 ± 0.71 |
| Session 1: Sodium, Day 26, n=2 | 0.5 ± 3.54 |
| Session 2: Sodium, Day1-pre-dose, n=1 | 1.0 ± NA |
| Session 2: Sodium, Day 3, n=1 | 4.0 ± NA |
| Session 2: Sodium, Day 5, n=1 | 2.0 ± NA |
| Session 2: Sodium, Day 7, n=1 | 1.0 ± NA |
| Session 2: Sodium, Day 10, n=1 | 3.0 ± NA |
| Session 2: Sodium, Day 26, n=1 | 0.0 ± NA |
| Session 1: Urea, Day 3, n=2 | 0.85 ± 1.202 |
| Session 1: Urea, Day 5, n=2 | 1.00 ± 3.111 |
| Session 1: Urea, Day 7, n=2 | -0.25 ± 1.344 |
| Session 1: Urea, Day 10, n=2 | -0.20 ± 0.707 |
| Session 1: Urea, Day 26, n=2 | 0.70 ± 1.273 |
| Session 2: Urea, Day1-pre-dose, n=1 | -0.10 ± NA |
| Session 2: Urea, Day 3, n=1 | 1.00 ± NA |
| Session 2: Urea, Day 5, n=1 | 0.70 ± NA |
| Session 2: Urea, Day 7, n=1 | 0.10 ± NA |
| Session 2: Urea, Day 10, n=1 | 0.10 ± NA |
| Session 2: Urea, Day 26, n=1 | 0.10 ± NA |
Blood samples were planned to be collected to analyze the chemistry parameters.
No measurements were reported for this outcome.
Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Grams per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Albumin, Day 3, n=2 | -2.0 ± 1.41 |
| Session 1: Albumin, Day 5, n=2 | -2.0 ± 1.41 |
| Session 1: Albumin, Day 7, n=2 | -1.0 ± 2.83 |
| Session 1: Albumin, Day 10, n=2 | -2.0 ± 4.24 |
| Session 1: Albumin, Day 26, n=2 | 0.5 ± 3.54 |
| Session 2: Albumin, Day1-pre-dose, n=1 | -1.0 ± NA |
| Session 2: Albumin, Day 3, n=1 | -4.0 ± NA |
| Session 2: Albumin, Day 5, n=1 | -4.0 ± NA |
| Session 2: Albumin, Day 7, n=1 | -4.0 ± NA |
| Session 2: Albumin, Day 10, n=1 | -6.0 ± NA |
| Session 2: Albumin, Day 26, n=1 | -4.0 ± NA |
| Session 1: Protein, Day 3, n=2 | -2.5 ± 0.71 |
| Session 1: Protein, Day 5, n=2 | -6.0 ± 2.83 |
| Session 1: Protein, Day 7, n=2 | -3.0 ± 1.41 |
| Session 1: Protein, Day 10, n=1 | -8.0 ± NA |
| Session 1: Protein, Day 26, n=2 | 2.5 ± 9.19 |
| Session 2: Protein, Day1-pre-dose, n=1 | -3.0 ± NA |
| Session 2: Protein, Day 3, n=1 | -8.0 ± NA |
| Session 2: Protein, Day 7, n=1 | -5.0 ± NA |
| Session 2: Protein, Day 10, n=1 | -7.0 ± NA |
| Session 2: Protein, Day 26, n=1 | -5.0 ± NA |
Blood samples were planned to be collected to analyze the chemistry parameters.
No measurements were reported for this outcome.
Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| International units per liter | Part A: Anti-SAP |
|---|---|
| Session 1: ALP, Day 3, n=2 | -8.0984 ± 5.51433 |
| Session 1: ALP, Day 5, n=2 | 0.2999 ± 17.39135 |
| Session 1: ALP, Day 7, n=1 | 7.7984 ± NA |
| Session 1: ALP, Day 10, n=2 | -2.0996 ± 2.96925 |
| Session 1: ALP, Day 26, n=2 | -2.3995 ± 5.09015 |
| Session 2: ALP, Day1-pre-dose, n=1 | 4.1992 ± NA |
| Session 2: ALP, Day 3, n=1 | 1.7996 ± NA |
| Session 2: ALP, Day 5, n=1 | 2.9994 ± NA |
| Session 2: ALP, Day 7, n=1 | -1.7996 ± NA |
| Session 2: ALP, Day 10, n=1 | -0.5999 ± NA |
| Session 2: ALP, Day 26, n=1 | 0.5999 ± NA |
| Session 1: ALT, Day 3, n=2 | -1.7647 ± 2.49569 |
| Session 1: ALT, Day 5, n=2 | -3.5294 ± 4.99138 |
| Session 1: ALT, Day 7, n=2 | -0.2941 ± 0.41595 |
| Session 1: ALT, Day 10, n=2 | 1.1765 ± 1.66379 |
| Session 1: ALT, Day 26, n=2 | -2.9412 ± 4.15948 |
| Session 2: ALT, Day1-pre-dose, n=1 | 0.0000 ± NA |
| Session 2: ALT, Day 3, n=1 | 0.0000 ± NA |
| Session 2: ALT, Day 5, n=1 | 0.0000 ± NA |
| Session 2: ALT, Day 7, n=1 | 0.0000 ± NA |
| Session 2: ALT, Day 10, n=1 | 0.0000 ± NA |
| Session 2: ALT, Day 26, n=1 | 0.0000 ± NA |
| Session 1: AST, Day 3, n=2 | -5.3989 ± 4.24179 |
| Session 1: AST, Day 5, n=2 | -7.1986 ± 7.63523 |
| Session 1: AST, Day 7, n=2 | -3.2993 ± 1.27254 |
| Session 1: AST, Day 10, n=2 | -2.9994 ± 0.84836 |
| Session 1: AST, Day 26, n=2 | -3.2993 ± 5.51433 |
| Session 2: AST, Day1-pre-dose, n=1 | -0.5999 ± NA |
| Session 2: AST, Day 3, n=1 | -5.3989 ± NA |
| Session 2: AST, Day 5, n=1 | -4.7990 ± NA |
| Session 2: AST, Day 7, n=1 | -4.1992 ± NA |
| Session 2: AST, Day 10, n=1 | -5.3989 ± NA |
| Session 2: AST, Day 26, n=1 | -4.1992 ± NA |
Blood samples were planned to be collected to analyze the chemistry parameters.
No measurements were reported for this outcome.
Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
| Micromoles per liter | Part A: Anti-SAP |
|---|---|
| Session 1: Direct Bilirubin, Day 3, n=2 | -2.70 ± 2.121 |
| Session 1: Direct Bilirubin, Day 5, n=2 | -4.35 ± 2.051 |
| Session 1: Direct Bilirubin, Day 7, n=2 | -3.75 ± 3.323 |
| Session 1: Direct Bilirubin, Day 10, n=2 | -2.80 ± 3.111 |
| Session 1: Direct Bilirubin, Day 26, n=2 | -1.70 ± 0.707 |
| Session 2: Direct Bilirubin, Day1-pre-dose, n=1 | 0.30 ± NA |
| Session 2: Direct Bilirubin, Day 3, n=1 | -0.30 ± NA |
| Session 2: Direct Bilirubin, Day 5, n=1 | 0.60 ± NA |
| Session 2: Direct Bilirubin, Day 7, n=1 | 0.00 ± NA |
| Session 2: Direct Bilirubin, Day 10, n=1 | -0.50 ± NA |
| Session 2: Direct Bilirubin, Day 26, n=1 | -0.50 ± NA |
| Session 1: Bilirubin, Day 3, n=2 | -9.30 ± 6.647 |
| Session 1: Bilirubin, Day 5, n=2 | -12.30 ± 8.061 |
| Session 1: Bilirubin, Day 7, n=2 | -11.85 ± 7.283 |
| Session 1: Bilirubin, Day 10, n=2 | -9.55 ± 9.122 |
| Session 1: Bilirubin, Day 26, n=2 | -5.10 ± 1.273 |
| Session 2: Bilirubin, Day1-pre-dose, n=1 | 0.00 ± NA |
| Session 2: Bilirubin, Day 3, n=1 | -2.00 ± NA |
| Session 2: Bilirubin, Day 5, n=1 | 0.00 ± NA |
| Session 2: Bilirubin, Day 7, n=1 | -1.20 ± NA |
| Session 2: Bilirubin, Day 10, n=1 | -2.40 ± NA |
| Session 2: Bilirubin, Day 26, n=1 | -2.70 ± NA |
| Session 1: Creatinine, Day 3, n=2 | 6.5 ± 6.36 |
| Session 1: Creatinine, Day 5, n=2 | -4.5 ± 2.12 |
| Session 1: Creatinine, Day 7, n=2 | 1.0 ± 0.00 |
| Session 1: Creatinine, Day 10, n=2 | 1.0 ± 9.90 |
| Session 1: Creatinine, Day 26, n=2 | 13.0 ± 1.41 |
| Session 2: Creatinine, Day1-pre-dose, n=1 | -1.0 ± NA |
| Session 2: Creatinine, Day 3, n=1 | 0.0 ± NA |
| Session 2: Creatinine, Day 5, n=1 | -11.0 ± NA |
| Session 2: Creatinine, Day 7, n=1 | 0.0 ± NA |
| Session 2: Creatinine, Day 10, n=1 | 1.0 ± NA |
| Session 2: Creatinine, Day 26, n=1 | -2.0 ± NA |
Blood samples were planned to be collected to analyze the chemistry parameters.
No measurements were reported for this outcome.
Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones | 2 |
Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen.
| Participants | Part A: Anti-SAP |
|---|---|
| Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen | 0 |
Urine samples were planned to be collected to analyze the urinalysis parameters.
No measurements were reported for this outcome.
Urine samples were planned to be collected to analyze the urinalysis parameters.
No measurements were reported for this outcome.
Collected over AEs and SAEs were collected up to Day 26 of the last session. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Anti-SAP | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Part A: Anti-SAP |
|---|---|
| HeadacheNervous system disorders | 2/2 |
| Restless legs syndromeNervous system disorders | 1/2 |
| Dry eyeEye disorders | 1/2 |
| DiarrhoeaGastrointestinal disorders | 1/2 |
| Injection site bruisingGeneral disorders | 1/2 |
| DactylitisMusculoskeletal and connective tissue disorders | 1/2 |
| Urticarial vasculitisSkin and subcutaneous tissue disorders | 1/2 |
The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment) during Part A; hence, no participants were enrolled in Part B.
| Age, Continuous(Years) | Part A: Anti-SAP | Part B: Anti-SAP | Total |
|---|---|---|---|
| Mean | 77.5 ± 3.54 | — | 77.5 ± 3.54 |
| Sex: Female, Male(Participants) | Part A: Anti-SAP | Part B: Anti-SAP | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 1 | — | 1 |
| Race/Ethnicity, Customized(Participants) | Part A: Anti-SAP | Part B: Anti-SAP | Total |
|---|---|---|---|
| White | 2 | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Apr 2018 to primary completion in Jul 2018, 3 months.
Results were first posted in Aug 2019, 1 year 1 month after primary completion.
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Studies of the drug tested here: Dezamizumab