A Phase 1 interventional study of Danirixin and Omeprazole in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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Among 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline — 7 open to participants now, 8 under way, 5 of them phase 3. Pulmonary Disease, Chronic Obstructive · GlaxoSmithKline.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 161st largest by enrollment of the 236 interventional ones that give a count, is one of 12 that started in 2018, is one of 83 in phase 1, and was the 248th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →7 of the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina
Ages 40–80
GlaxoSmithKline · Sites in United States, Japan
Ages 40–80
GlaxoSmithKline · Sites in United Kingdom
Ages 18–55 · Healthy volunteers
GlaxoSmithKline · Sites in United States, Australia, Bulgaria and 10 more countries
Ages 40–75
GlaxoSmithKline · Sites in United States, Argentina, Australia and 13 more countries
Ages 40–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 65 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
276 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 84 · Phase 2 47 · Phase 3 65 · Phase 4 38
First in 2000; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 101 across the 236 interventional studies, 1,248 across the 40 observational. Of the 264 that completed or were terminated, 141 (53%) 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.
2 of the studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06154837GlaxoSmithKlineA Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | 2026-12-16 |
| NCT07789899GlaxoSmithKlineA Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants | 2027-09-07 |
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Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations. Part A will support the selection of the formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK) profile of selected formulation from Part A. Danirixin is currently administered with food, therefore the investigation of food effect for the selected formulation could potentially enable dosing without food. Approximately 16 subjects will be included in Part A and approximately 24 subjects will be included in Part B. Both parts will include a screening phase, treatment phase with in-between washout period and a follow-up phase.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Subjects will receive a single oral dose of 50 mg danirixin reference and test formulations with food and 240 mL of water in a cross-over manner.
Drug: Danirixin
Subjects will receive a single oral dose of 50 mg danirixin formulation (selected in Part A) in fasted or fed state in a cross-over manner.
Drug: Danirixin
Subjects will receive a single oral dose of 50 mg danirixin formulation (selected in Part A) along with once daily 40 mg OMP capsule in fasted or fed state in a cross-over manner.
Drug: Danirixin · Drug: Omeprazole
Danirixin is being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disorder (COPD) and other inflammatory diseases and influenza. Danirixin reference (600 mg) or test formulation (475 or 600 mg or 600 mg with 5 percent HPMC) immediate release tablets will be administered by oral route in a cross-over manner.
Omeprazole is used as an antacid. OMP 40 mg delayed-release capsule will be administered by oral route to randomized subjects.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Maximum Observed Concentration (Cmax) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events (SAEs) in Part 1
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time frame: Up to 29 days in Part 1
Number of Participants With Vital Signs of Potential Clinical Concern in Part 1
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
Time frame: Up to 29 days in Part 1
Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 1
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 1 are presented.
Time frame: Up to 29 days in Part 1
Number of Participants With Laboratory Values of Potential Clinical Concern in Part 1
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium alanine, aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
Time frame: Up to 29 days in Part 1
Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC [0-24]) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Time to Occurrence of Cmax (Tmax) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Terminal Half-life (t1/2) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Danirixin for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Maximum Observed Concentration (Cmax) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Time to Maximum Observed Concentration (Tmax) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Terminal Half-life (t1/2) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Lag Time Before Observable Concentration (Tlag) of Danirixin for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time frame: Up to 52 days in Part 2
Number of Participants With Vital Signs of Potential Clinical Concern in Part 2
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
Time frame: Up to 52 days in Part 2
Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 2
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 2 are presented.
Time frame: Up to 52 days in Part 2
Number of Participants With Laboratory Values of Potential Clinical Concern in Part 2
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate, Aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct, bilirubin, creatinine sodium alanine, Aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
Time frame: Up to 52 days in Part 2
This two-part study assessed the relative bioavailability of Danirixin (DNX) tablet formulations along with effect of food and gastric acid secretion suppression on DNX pharmacokinetics. This study was conducted at a single center in the United States from 07-Mar-2018 to 25-Jul-2018.
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 8 | 8 | 0 | 0 |
| Completed | 8 | 8 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 12 |
| Completed | 0 | 0 | 12 | 12 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 12 |
| Completed | 0 | 0 | 12 | 11 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 11 |
| Completed | 0 | 0 | 12 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 11 |
| Completed | 0 | 0 | 12 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 11 |
| Completed | 0 | 0 | 12 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 11 |
| Completed | 0 | 0 | 12 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State |
|---|---|---|---|---|
| Started | 0 | 0 | 12 | 0 |
| Completed | 0 | 0 | 12 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms per milliliter | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 1 | 6166.7 ± 19.20 | 6052.9 ± 14.18 | 5816.4 ± 22.99 | 5996.1 ± 26.31 | 11394.6 ± 30.07 | 11285.7 ± 32.72 | 10957.4 ± 31.55 | 11230.8 ± 28.21 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Nanograms/milliliter | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) of Danirixin for Part 1 | 761.5 ± 27.22 | 712.8 ± 20.53 | 762.3 ± 37.23 | 659.2 ± 47.40 | 2708.2 ± 26.22 | 2418.5 ± 27.78 | 2607.1 ± 30.24 | 2511.8 ± 24.19 |
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
| Participants | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Any AE | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 1 |
| Any SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
| Participants | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Vital Signs of Potential Clinical Concern in Part 1 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 |
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 1 are presented.
| Participants | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 1 | 1 | 2 | 2 | 2 | 2 | 1 | 2 | 1 |
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium alanine, aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
| Participants | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Laboratory Values of Potential Clinical Concern in Part 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms/milliliter | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 1 | 5515.9 ± 24.54 | 5573.6 ± 17.65 | 5524.7 ± 22.15 | 5287.0 ± 28.27 | 11480.1 ± 28.07 | 10977.2 ± 30.52 | 10636.5 ± 32.09 | 11015.8 ± 28.35 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms/milliliter | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC [0-24]) of Danirixin for Part 1 | 4919.5 ± 27.19 | 4952.0 ± 18.25 | 4984.8 ± 24.27 | 4705.2 ± 27.96 | 10744.8 ± 26.07 | 10419.9 ± 27.78 | 10029.3 ± 32.19 | 10319.9 ± 26.14 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Time to Occurrence of Cmax (Tmax) of Danirixin for Part 1 | 3.897 ± 0.9894 | 3.653 ± 0.5089 | 3.585 ± 1.2942 | 4.158 ± 1.3556 | 1.165 ± 0.3794 | 1.331 ± 0.7536 | 1.214 ± 0.2669 | 1.342 ± 0.3768 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Terminal Half-life (t1/2) of Danirixin for Part 1 | 9.638 ± 17.60 | 10.904 ± 19.33 | 8.916 ± 29.74 | 9.888 ± 26.18 | 8.298 ± 36.18 | 9.498 ± 26.76 | 9.391 ± 45.40 | 9.107 ± 29.56 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 1 | 47.660 ± 0.2178 | 47.587 ± 0.2200 | 44.657 ± 8.3551 | 44.757 ± 8.3813 | 44.372 ± 8.9730 | 41.789 ± 10.9667 | 41.699 ± 10.9179 | 44.531 ± 8.3335 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted |
|---|---|---|---|---|---|---|---|---|
| Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Danirixin for Part 1 | 0.323 ± 0.3812 | 0.383 ± 0.5917 | 0.383 ± 0.5918 | 0.511 ± 0.6661 | 0.000 ± 0.000 | 0.065 ± 0.1830 | 0.000 ± 0.0000 | 0.000 ± 0.0000 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms/milliliter | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 2 | 12426.4 ± 35.85 | 7761.2 ± 41.31 | 8136.7 ± 32.85 | 7356.4 ± 34.65 | 14615.2 ± 24.23 | 10185.0 ± 34.57 | 8782.5 ± 45.73 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms/milliliter | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 2 | 12026.9 ± 37.00 | 7484.2 ± 39.37 | 7757.2 ± 31.77 | 6986.9 ± 32.54 | 12903.9 ± 37.02 | 9023.8 ± 42.46 | 7885.4 ± 46.30 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours*nanograms/milliliter | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of Danirixin for Part 2 | 11096.7 ± 36.64 | 6482.2 ± 37.93 | 6706.6 ± 28.49 | 6187.1 ± 30.41 | 12762.9 ± 23.58 | 8681.0 ± 32.68 | 7590.8 ± 37.96 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Nanograms/milliliter | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) of Danirixin for Part 2 | 2317.4 ± 44.90 | 989.9 ± 47.91 | 969.9 ± 37.80 | 1019.8 ± 38.90 | 2292.5 ± 43.18 | 1389.7 ± 43.59 | 1132.5 ± 35.26 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of Danirixin for Part 2 | 1.271 ± 0.3374 | 3.749 ± 0.6458 | 4.150 ± 1.5008 | 3.355 ± 1.3724 | 1.978 ± 0.8770 | 2.887 ± 0.7802 | 3.752 ± 1.7384 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Terminal Half-life (t1/2) of Danirixin for Part 2 | 10.647 ± 26.80 | 11.424 ± 21.51 | 11.484 ± 11.21 | 11.652 ± 20.01 | 11.304 ± 15.02 | 10.913 ± 24.37 | 8.975 ± 33.78 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 2 | 45.139 ± 6.6767 | 47.144 ± 0.4440 | 47.200 ± 0.4262 | 46.741 ± 0.4843 | 45.217 ± 7.0764 | 45.242 ± 7.0723 | 40.869 ± 10.8896 |
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.
| Hours | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Lag Time Before Observable Concentration (Tlag) of Danirixin for Part 2 | 0.000 ± 0.0000 | 0.283 ± 0.3554 | 0.641 ± 0.4405 | 0.386 ± 0.4922 | 0.000 ± 0.0000 | 0.423 ± 0.3097 | 0.370 ± 0.6461 |
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
| Participants | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Any AE | 1 | 1 | 1 | 0 | 0 | 0 | 3 |
| Any SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.
| Participants | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Number of Participants With Vital Signs of Potential Clinical Concern in Part 2 | 2 | 3 | 4 | 4 | 4 | 3 | 4 |
Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 2 are presented.
| Participants | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 2 | 1 | 2 | 1 | 3 | 1 | 2 | 2 |
Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate, Aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct, bilirubin, creatinine sodium alanine, Aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.
| Participants | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC Fasted OMP | 475DC Normal Meal OMP | 475DC High Fat OMP |
|---|---|---|---|---|---|---|---|
| Number of Participants With Laboratory Values of Potential Clinical Concern in Part 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Collected over On-Treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment until 81 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 600RC High Fat | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 475DC High Fat | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 600DC High Fat | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 600DC 5%HPMC High Fat | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 600RC Fasted | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| 475DC Fasted | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 600DC Fasted | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 600DC 5%HPMC Fasted | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 475DC-Fasted | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| 475DC-Normal Meal | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| 475DC-High Fat | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| 475DC-MONO High Fat | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| 475DC-Fasted OMP | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| 475DC-Normal Meal OMP | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| 475DC-High Fat OMP | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | 600RC High Fat | 475DC High Fat | 600DC High Fat | 600DC 5%HPMC High Fat | 600RC Fasted | 475DC Fasted | 600DC Fasted | 600DC 5%HPMC Fasted | 475DC-Fasted | 475DC-Normal Meal | 475DC-High Fat | 475DC-MONO High Fat | 475DC-Fasted OMP | 475DC-Normal Meal OMP | 475DC-High Fat OMP |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 1/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 2/12 |
| DyspepsiaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 2/12 |
| Vessel puncture site haematomaGeneral disorders | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| Abnormal faecesGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| NauseaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| VomitingGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| BursitisMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/12 | 0/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| HeadacheNervous system disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/12 | 0/12 | 1/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| SomnolenceNervous system disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/12 | 1/12 | 0/12 | 0/12 | 0/11 | 0/11 | 0/12 |
| Age, Continuous(Years) | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State | Total |
|---|---|---|---|---|---|
| Mean | 69.4 ± 3.54 | 70.9 ± 4.58 | 71.3 ± 4.14 | 69.4 ± 2.68 | 70.3 ± 3.70 |
| Sex: Female, Male(Participants) | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State | Total |
|---|---|---|---|---|---|
| Female | 4 | 6 | 4 | 8 | 22 |
| Male | 4 | 2 | 8 | 4 | 18 |
| Race/Ethnicity, Customized(Count of Participants) | DNX 50 mg 600RC/475DC/600DC/600DC-5% HPMC in Fed State | DNX 50mg 600RC/475DC/600DC/600DC-5% HPMC in Fasted State | DNX 50 mg 475 DC Under Fasted/Normal/Fat Meal/ Mono-fat Meal | DNX 50 mg 475 DC+OMP 40mg Under Fasted/Normal/Fat Meal State | Total |
|---|---|---|---|---|---|
| Black or African American | 1 | 0 | 0 | 2 | 3 |
| White | 7 | 8 | 12 | 10 | 37 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
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 Mar 2018 to primary completion in Jul 2018, 4 months.
Results were first posted in Aug 2019, 1 year 1 month after primary completion.
Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 4 months is close to that.
Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Danirixin
Pulmonary Disease, Chronic Obstructive →