A Phase 1 interventional study of Daprodustat 2 mg tablet and Daprodustat 4 mg tablet in Anaemia, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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Among 30 studies testing GSK1278863 in Anemia — 1 open to participants now, 1 under way, 1 of them phase 3. GSK1278863 · Anemia.
Among the 30 studies testing GSK1278863 in Anemia, this one is the 18th largest by enrollment, is one of 3 that started in 2018, is one of 10 in phase 1, and was the 26th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →1 of the 30 studies testing GSK1278863 in Anemia is open now. Recruiting first, the newest first:
GSK1278863: first FDA approval 2023 (JESDUVROQ). What it is approved for, and how studies give it, is on its page →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 20 Years to 55 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 64 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 76 across the 30 interventional studies. Of the 29 that completed or were terminated, 23 (79%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 30 have an industry lead sponsor. The 3 most frequent:
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.
35 studies in Anemia by GlaxoSmithKline: none open now, none under way, none of them phase 3. Of 35 finished, 25 (71%) have results posted.
Among the 35 studies in Anemia by GlaxoSmithKline, this one is the 20th largest by enrollment, is one of 3 that started in 2018, is one of 14 in phase 1, and was the 32nd registered.
GlaxoSmithKline’s Anemia studies by the year they started, since 2006.
1 of the studies testing GSK1278863 in Anemia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07300111Phase 3Qilu Pharmaceutical Co., Ltd.A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) | 2027-05 |
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Among the 30 studies testing GSK1278863 in Anemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 35 in Anemia:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses in healthy Japanese male subjects. This study will be conducted in two parts. Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner. There will 5-day wash-out period between each intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in Part 2. The study will last for 6 weeks.
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.
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.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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 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.
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.
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.
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.
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.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
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.
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.
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.
Subjects will be randomized to receive single dose of two tablets of 2 mg daprodustat in Period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 2 mg tablet · Drug: Daprodustat 4 mg tablet
Subjects will be randomized to receive single dose of 4 mg daprodustat in Period 1 and in Period 2 subjects will receive single dose of two tablets of 2 mg daprodustat. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 2 mg tablet · Drug: Daprodustat 4 mg tablet
Subjects will be randomized to receive single dose of 4 mg daprodustat in fed state during Period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat in fasted state. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 4 mg tablet
Subjects will be randomized to receive single dose of 4 mg daprodustat in fasted state during period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat in fed state. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 4 mg tablet
Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study.
Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.
Part 1:Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Last Measurable Concentration (AUC[0-t]) and AUC From Zero Hours Extrapolated to Infinity AUC [0-inf] of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3. PK population comprised of all participants in the Safety population (all randomized participants) who received at least one dose of study intervention) who had at least 1 non-missing PK assessment.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1:Maximum Observed Drug Concentration (Cmax) of Daprodustat
Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1:Terminal Phase Half-life (T1/2) of Daprodustat and Mean Residence Time (MRT)
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1: Time of Occurrence of Cmax (Tmax) of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1: Percentage of AUC (0-inf) Obtained by Extrapolation (Percentage AUCex)
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1:Apparent Clearance (CL/F) of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1:Apparent Oral Volume of Distribution (Vz/F) of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1: Elimination Rate Constant (Kel) of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2
Part 2:AUC[0-t] andAUC [0-inf] of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2
Part 2: Cmax of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2
Part 2: T1/2 and MRT of Daprodustat
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2
Part 2: Tmax of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 2: Percentage AUCex of Dapordustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 2: CL/F of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 2: Vz/F of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 2: Kel of Daprodustat
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Safety population comprised of all randomized participants who took at least one dose of study treatment.
Time frame: Up to Day 16
Part 1: Change From Baseline Chemistry Paramters: Glucose, Calcium, Cholesterol, Chloride, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea.
Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate, sodium, triglycerides, and urea. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyl Transferase (GGT).
Blood samples were collected to analyze the chemistry parameters; ALP, ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Chemistry Parameters; Albumin, Protein.
Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1:Change From Baseline in Hematology Parameter; Hematocrit
Blood samples were collected to analyze hematology parameters; hematocrit, reticulocytes. Platelets. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1:Change From Baseline in Hematology Parameter; Reticulocytes
Blood samples were collected to analyze hematology parameters; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameters; Hemoglobin (Hb), Erythrocyte Mean Corpuscular Hb Concentration (MCHC)
Blood samples were collected to analyze hematology parameters; Hb, EMCH concentration. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophil. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameter Erythrocyte MCHC
Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameter Erythrocyte Mean Corpuscular Volume (EMCV)
Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 1.Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Urinalysis Parameter; Specific Gravity
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 1. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24hours post-dose
Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), 3 and 24 hours (post-dose)
Part 1: Change From Baseline in Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), 3 and 24 hours (post-dose)
Part 1: Change From Baseline in Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), 3 and 24 hours (post-dose)
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameter; Mean Heart Rate (HR)
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), 3 and 24 hours (post-dose)
Part 1: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QT Duration Corrected for Heart Rate by Friderician Formula (QTcF) Interval
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), 3 and 24 hours (post-dose)
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Safety population comprised of all randomized participants who took at least one dose of study treatment.
Time frame: Up to Day 16
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate,sodium, triglycerides, and urea. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
Blood samples were collected to analyze the chemistry parameters; ALP,ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Chemistry Parameters; Albumin, Protein
Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameters; Hematocrit
Blood samples were collected to analyze hematology parameter; hematocrit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameters; Reticulocytes
Blood samples were collected to analyze hematology parameter; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameters; Hb, Erythrocyte MCHC
Blood samples were collected to analyze hematology parameters; Hb, erythrocyte MCHC. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophils. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameter: EMCH
Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameter EMCV
Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Hematology Parameter Erythrocytes
Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 2. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Urinalysis Parameter; Specific Gravity
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 2. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
Time frame: Baseline (Day -1), 24 hours (post-dose)
Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time point. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1),3 and 24hours (pre-dose)
Part 2: Change From Baseline in Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1),3 and 24hours (pre-dose)
Part 2: Change From Baseline in Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1),3 and 24hours (pre-dose)
Part 2: Change From Baseline in ECG Parameter; Mean Heart Rate (HR)
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1),3 and 24hours (pre-dose)
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1),3 and 24hours (pre-dose)
A single center, single dose, open-label, randomized, 2-way crossover study in healthy Japanese male participants to evaluate the bioequivalence of daprodustat tablets, study was conducted at one center in Japan.
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 26 | 26 | 0 | 0 |
| Completed | 26 | 26 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 26 | 26 | 0 | 0 |
| Completed | 26 | 25 | 0 | 0 |
| Not completed | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 26 | 25 | 0 | 0 |
| Completed | 26 | 25 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 0 | 0 | 6 | 6 |
| Completed | 0 | 0 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 0 | 0 | 6 | 6 |
| Completed | 0 | 0 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1 | Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2 | Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast) | Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed) |
|---|---|---|---|---|
| Started | 0 | 0 | 6 | 6 |
| Completed | 0 | 0 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3. PK population comprised of all participants in the Safety population (all randomized participants) who received at least one dose of study intervention) who had at least 1 non-missing PK assessment.
| Hour*nanogram/milliliter | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| AUC (0-t) | 182.8420 ± 30.7 | 179.6940 ± 30.4 |
| AUC (0-inf) | 183.0240 ± 30.7 | 179.8710 ± 30.4 |
Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Nanogram/milliliter | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1:Maximum Observed Drug Concentration (Cmax) of Daprodustat | 88.8811 ± 37.0 | 85.1365 ± 37.0 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| hour | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| t1/2 | 3.2427 ± 14.9 | 3.2579 ± 11.8 |
| MRT | 2.8142 ± 25.9 | 2.9637 ± 23.2 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| hour | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Time of Occurrence of Cmax (Tmax) of Daprodustat | 2.000 (1.00 to 4.00) | 2.000 (1.00 to 4.00) |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Percentage of AUCex | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Percentage of AUC (0-inf) Obtained by Extrapolation (Percentage AUCex) | 0.0862 ± 53.5 | 0.0836 ± 55.3 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Liters per hour | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1:Apparent Clearance (CL/F) of Daprodustat | 21.8551 ± 30.7 | 22.2382 ± 30.4 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Milliliters (mL) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1:Apparent Oral Volume of Distribution (Vz/F) of Daprodustat | 102244.3 ± 33.2 | 104522.8 ± 30.8 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Per hour | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Elimination Rate Constant (Kel) of Daprodustat | 0.2138 ± 14.9 | 0.2128 ± 11.8 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Hour*nanogram/milliliter | Daprodustat 4mg (Fed) | Daprodustat 4mg(Fasted) |
|---|---|---|
| AUC (0-t) | 142.9556 ± 18.0 | 156.4222 ± 19.3 |
| AUC (0-inf) | 143.1156 ± 18.0 | 156.5481 ± 19.2 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Nanogram/milliliter (ng/L) | Daprodustat 4mg Fed | Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: Cmax of Daprodustat | 67.8240 ± 26.7 | 76.1944 ± 29.8 |
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| hour | Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| t1/2 | 3.2160 ± 9.7 | 3.2389 ± 8.0 |
| MRT | 3.2420 ± 25.2 | 2.6695 ± 26.8 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| hour | Part 2: Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: Tmax of Daprodustat | 2.750 (1.00 to 3.00) | 1.750 (1.00 to 4.00) |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Percentage of AUCex | Part 2: Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: Percentage AUCex of Dapordustat | 0.1071 ± 30.9 | 0.0723 ± 47.9 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Liters per hour | Part 2: Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: CL/F of Daprodustat | 27.9494 ± 18.0 | 25.5512 ± 19.2 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Milliliters (mL) | Part 2: Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: Vz/F of Daprodustat | 129676.9 ± 18.7 | 119394.6 ± 19.7 |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.
| Per hour | Part 2: Daprodustat 4mg Fed | Part 2: Daprodustat 4mg Fasted |
|---|---|---|
| Part 2: Kel of Daprodustat | 0.2155 ± 9.7 | 0.2140 ± 8.0 |
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Safety population comprised of all randomized participants who took at least one dose of study treatment.
| Participants | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Any AE | 3 | 1 |
| Any SAE | 0 | 0 |
Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate, sodium, triglycerides, and urea. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Millimoles per Liter (mmol/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Glucose 24hours | -0.007619 ± 0.3094690 | -0.004270 ± 0.3243933 |
| Calcium 24hours | -0.016144 ± 0.0694710 | -0.015834 ± 0.0623072 |
| Cholesterol 24hours | -0.043607 ± 0.3197656 | 0.046747 ± 0.2952955 |
| Chloride 24hours | 0.9 ± 1.74 | 0.5 ± 1.63 |
| HDL cholesterol 24hours | -0.128793 ± 0.1230991 | -0.111397 ± 0.1067511 |
| LDL cholesterol 24hours | 0.022818 ± 0.2151606 | 0.099462 ± 0.2265669 |
| Potassium 24hours | 0.04 ± 0.295 | 0.03 ± 0.272 |
| Phosphate 24hours | -0.102568 ± 0.1114273 | -0.091281 ± 0.1110710 |
| Sodium 24hours | 0.2 ± 1.37 | 0.0 ± 1.50 |
| Triglycerides 24hours | 0.21802 ± 0.273901 | 0.16385 ± 0.274955 |
| Urea 24hours | -0.14000 ± 0.767902 | -0.29178 ± 0.840240 |
Blood samples were collected to analyze the chemistry parameters; ALP, ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| International unit per liter (IU/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| ALP 24hours | -9.5 ± 17.24 | -10.8 ± 12.83 |
| ALT 24hours | -2.0 ± 3.65 | -1.0 ± 3.19 |
| AST 24hours | -2.1 ± 3.19 | -1.8 ± 3.22 |
| Creatine kinase 24hours | -33.9 ± 28.73 | -32.3 ± 30.24 |
| GGT 24hours | -1.6 ± 2.34 | -1.1 ± 1.34 |
| Lactate dehydrogenase 24hours | -20.5 ± 12.30 | -19.2 ± 9.15 |
Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Grams per liter (g/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Albumin 24hours | -2.0 ± 1.74 | -2.0 ± 1.69 |
| Protein 24hours | -2.3 ± 2.90 | -2.1 ± 2.35 |
Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Micromoles per liter (umol/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Direct bilirubin 24hours | 0.268 ± 0.7151 | 0.164 ± 0.6989 |
| Bilirubin 24hours | 2.615 ± 5.0537 | 2.960 ± 4.7784 |
| Creatinine 24hours | 1.7160 ± 4.18539 | 1.4110 ± 4.84901 |
| Urate 24hours | 26.1245 ± 28.30344 | 25.6222 ± 28.35581 |
Blood samples were collected to analyze hematology parameters; hematocrit, reticulocytes. Platelets. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Proportion of red blood cells in blood | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1:Change From Baseline in Hematology Parameter; Hematocrit | 0.0005 ± 0.01593 | 0.0014 ± 0.01464 |
Blood samples were collected to analyze hematology parameters; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Praportion of reticulocytes in blood | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1:Change From Baseline in Hematology Parameter; Reticulocytes | -0.0005 ± 0.00179 | -0.0001 ± 0.00189 |
Blood samples were collected to analyze hematology parameters; Hb, EMCH concentration. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Grams per Liter (g/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Hb 24hours | 1.1 ± 5.81 | 0.8 ± 4.99 |
| MCHC 24hours | 2.1 ± 4.23 | 0.8 ± 4.99 |
Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophil. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Percentage of cells | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Basophils 24hours | -0.01 ± 0.173 | 0.00 ± 0.197 |
| Eosinophils 24hours | 0.27 ± 0.871 | 0.25 ± 0.874 |
| Lymphocytes 24hours | -1.47 ± 6.070 | -0.86 ± 7.049 |
| Monocytes 24hours | -0.43 ± 1.293 | -0.33 ± 1.108 |
| Neutrophils 24hours | 1.64 ± 6.407 | 0.94 ± 7.480 |
Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Picograms (pg) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Change From Baseline in Hematology Parameter Erythrocyte MCHC | 0.11 ± 0.331 | 0.01 ± 0.319 |
Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Femtoliters | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Change From Baseline in Hematology Parameter Erythrocyte Mean Corpuscular Volume (EMCV) | -0.2 ± 0.75 | -0.2 ± 0.83 |
Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Billion cells per liter (10^9/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Platelets 24hours | 0.7 ± 13.21 | 2.0 ± 14.97 |
| Leukocytes 24hours | -0.55 ± 0.883 | -0.53 ± 0.928 |
Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Trillion cells/liter (10^12 cell/L) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | 0.018 ± 0.1941 | 0.023 ± 0.1771 |
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 1.Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| pH | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH) | -0.04 ± 0.573 | -0.07 ± 0.714 |
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 1. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Kilogram per cubic meter | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Part 1: Change From Baseline in Urinalysis Parameter; Specific Gravity | 0.0092 ± 0.00744 | 0.0088 ± 0.00767 |
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Millimeters of mercury (mmHg) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| DBP 3hours | -2.9 ± 5.84 | -1.5 ± 7.00 |
| DBP 24hours | -1.8 ± 6.38 | 0.1 ± 7.67 |
| SBP 3hours | -0.6 ± 7.48 | -0.4 ± 7.92 |
| SBP 24hours | -0.9 ± 8.07 | 0.2 ± 8.93 |
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Beats per minute | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Pulse rate 3hours | 0.0 ± 6.91 | 0.7 ± 4.78 |
| Pulse rate 24hours | 0.1 ± 6.04 | 1.0 ± 5.12 |
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Celcius (c) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Temperature 3hours | 0.23 ± 0.256 | 0.22 ± 0.311 |
| Temperature 24hours | 0.10 ± 0.212 | 0.05 ± 0.330 |
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Beats per minute | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| Mean HR 3hours | 0.6 ± 5.01 | 0.2 ± 4.21 |
| Mean HR 24hours | 1.2 ± 4.28 | 0.8 ± 5.18 |
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Milliseconds (msec) | Part 1: Daprodustat 2mg*2 | Part 1: Daprodustat 4mg*1 |
|---|---|---|
| PR Interval, Aggregate 3hours | -3.3 ± 10.87 | -3.8 ± 9.40 |
| PR Interval, Aggregate 24hours | 1.4 ± 8.13 | 0.0 ± 12.55 |
| QRS Duration, Aggregate 3hours | -2.8 ± 6.50 | -1.5 ± 6.42 |
| QRS Duration, Aggregate 24hours | -1.6 ± 6.62 | 0.2 ± 6.50 |
| QT interval, Aggregate 3hours | 0.0 ± 20.31 | 0.8 ± 17.63 |
| QT interval, Aggregate 24hours | -5.2 ± 17.42 | -5.3 ± 18.33 |
| QTcF interval, Aggregate 3hours | 1.2 ± 14.98 | 1.6 ± 14.73 |
| QtcF Interval, Aggregate 24hours | -2.4 ± 13.65 | -3.1 ± 13.70 |
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Safety population comprised of all randomized participants who took at least one dose of study treatment.
| Participants | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Any AE | 0 | 0 |
| Any SAE | 0 | 0 |
Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate,sodium, triglycerides, and urea. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Millimoles per Liter (mmol/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Glucose, 24hours | -0.425577 ± 0.2902134 | -0.018503 ± 0.2530908 |
| Calcium, 24hours | -0.076929 ± 0.0515273 | -0.058217 ± 0.0595515 |
| Cholesterol, 24hours | -0.172400 ± 0.2567913 | -0.094820 ± 0.2225472 |
| Chloride, 24hours | 1.5 ± 1.45 | 2.1 ± 2.27 |
| HDL cholesterol, 24hours | -0.165935 ± 0.0995210 | -0.148695 ± 0.0826086 |
| LDL cholesterol, 24hours | -0.170245 ± 0.1823445 | -0.066805 ± 0.1724049 |
| Potassium, 24hours | 0.06 ± 0.294 | 0.19 ± 0.231 |
| Phosphate, 24hours | -0.029599 ± 0.0928311 | -0.080725 ± 0.1324212 |
| Sodium, 24hours | 0.3 ± 2.35 | 0.9 ± 1.38 |
| Triglycerides, 24hours | 0.25331 ± 0.219827 | 0.08475 ± 0.197228 |
| Urea, 24hours | 0.19040 ± 0.552713 | -0.14875 ± 0.588353 |
Blood samples were collected to analyze the chemistry parameters; ALP,ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| International unit per liter (IU/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| ALP, 24hours | -18.9 ± 15.48 | -13.3 ± 10.54 |
| ALT, 24hours | -3.1 ± 2.43 | -3.5 ± 2.02 |
| AST, 24hours | -2.8 ± 2.18 | -2.7 ± 2.46 |
| Creatine kinase, 24hours | -28.3 ± 13.70 | -15.3 ± 17.56 |
| Lactate dehydrogenase, 24hours | -21.0 ± 9.68 | -18.4 ± 9.05 |
| GGT, 24hours | -1.0 ± 1.41 | -1.6 ± 2.11 |
Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Grams per liter (g/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Albumin 24hours | -3.2 ± 1.34 | -1.9 ± 1.16 |
| Protein 24hours | -3.4 ± 2.94 | -2.6 ± 2.02 |
Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Micromoles per liter (umol/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Direct bilirubin, 24hours | 0.000 ± 0.000 | 0.000 ± 1.0312 |
| Bilirubin, 24hours | 2.280 ± 5.2748 | 1.425 ± 3.1643 |
| Creatinine, 24hours | -1.6207 ± 5.16603 | -1.1050 ± 5.68072 |
| Urate, 24hours | 23.2963 ± 20.98470 | 21.8093 ± 19.53615 |
Blood samples were collected to analyze hematology parameter; hematocrit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Praportion of red blood cells in blood | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Hematology Parameters; Hematocrit | -0.0052 ± 0.01629 | -0.0025 ± 0.01519 |
Blood samples were collected to analyze hematology parameter; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Praportion of reticulocytes in blood | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Hematology Parameters; Reticulocytes | -0.0002 ± 0.00164 | -0.0010 ± 0.00186 |
Blood samples were collected to analyze hematology parameters; Hb, erythrocyte MCHC. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Grams per liter (g/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Hb 24hours | -2.1 ± 5.28 | -1.2 ± 5.37 |
| EMCH concentration 24hours | 0.4 ± 5.55 | -0.6 ± 4.66 |
Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophils. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Percentage of cells | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Basophils, 24hours | -0.04 ± 0.193 | -0.17 ± 0.239 |
| Eosinophils, 24hours | 0.62 ± 1.620 | -0.49 ± 0.312 |
| Lymphocytes, 24hours | -2.31 ± 3.815 | -1.14 ± 6.015 |
| Monocytes, 24hours | -0.38 ± 0.732 | -0.03 ± 1.414 |
| Neutrophils, 24hours | 2.12 ± 5.072 | 1.83 ± 5.829 |
Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| picograms | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Hematology Parameter: EMCH | 0.10 ± 0.413 | 0.03 ± 0.311 |
Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Femtoliters | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Hematology Parameter EMCV | 0.5 ± 0.67 | 0.3 ± 0.97 |
Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Billion cells per liter (10^9/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Platelets, 24hours | -10.9 ± 11.19 | -3.2 ± 12.04 |
| Leukocytes, 24hours | -0.27 ± 0.780 | -0.39 ± 0.579 |
Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Trillion cells/liter (10^12 cell/L) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Hematology Parameter Erythrocytes | -0.083 ± 0.1859 | -0.044 ± 0.1767 |
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 2. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| pH | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH) | 0.13 ± 0.433 | 0.13 ± 0.608 |
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 2. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.
| Kilogram per cubic meter | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Part 2: Change From Baseline in Urinalysis Parameter; Specific Gravity | 0.0054 ± 0.01215 | 0.0013 ± 0.00900 |
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time point. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Millimeters of mercury (mmHg) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| DBP, 3hours | -4.8 ± 4.90 | 0.2 ± 5.61 |
| DBP, 24hours | -0.6 ± 7.14 | 2.8 ± 6.97 |
| SBP, 3hours | 0.7 ± 6.10 | -1.3 ± 8.41 |
| SBP, 24hours | 1.4 ± 6.93 | 1.3 ± 5.18 |
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Beats per minute | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Pulse rate, 3hours | 6.1 ± 5.37 | -1.5 ± 5.82 |
| Pulse rate, 24hours | 4.0 ± 5.24 | 2.9 ± 6.05 |
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| celcius | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Temperature, 3hours | 0.28 ± 0.302 | 0.13 ± 0.293 |
| Temperature, 24hours | 0.02 ± 0.424 | 0.03 ± 0.245 |
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Beats/minute | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| Mean HR, 3hours | 3.7 ± 6.18 | 0.0 ± 4.07 |
| Mean HR, 24hours | 3.1 ± 6.60 | 0.6 ± 4.72 |
Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
| Milliseconds (msec) | Part 2: Daprodustat 4mg (Fed) | Part 2: Daprodustat 4mg (Fasted) |
|---|---|---|
| PR Interval, Aggregate, 3hours | -6.2 ± 6.00 | -2.7 ± 9.55 |
| PR Interval, Aggregate, 24hours | -4.0 ± 7.53 | -3.2 ± 7.11 |
| QRS Duration, Aggregate, 3hours | -1.5 ± 4.52 | -0.5 ± 5.13 |
| QRS Duration, Aggregate, 24hours | -0.8 ± 4.39 | 2.8 ± 7.93 |
| QT interval, Aggregate, 3hours | -13.0 ± 15.81 | 1.0 ± 16.28 |
| QT Interval, Aggregate, 24hours | -7.3 ± 13.73 | -2.2 ± 12.34 |
| QTcF Interval, Aggregate, 3hours | -5.3 ± 11.93 | 1.2 ± 13.64 |
| QTcF Interval, Aggregate, 24hours | -0.6 ± 12.87 | -1.1 ± 9.69 |
Collected over AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daprodustat 2mg*2 Followed by Daprodustat 4mg*1 | 0/51 (0%) | 0/51 (0%) | 3/51 (5.9%) |
| Daprodustat 4mg*1 Tablet Followed by Daprodustat 2mg*2tablets | 0/52 (0%) | 0/52 (0%) | 1/52 (1.9%) |
| Daprodustat 4mg*1 (Fed) Followed by Daprodustat 4mg*1 (Fasted) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Daprodustat 4mg*1 (Fasted) Followed by Daprodustat 4mg*1(Fed) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Daprodustat 2mg*2 Followed by Daprodustat 4mg*1 | Daprodustat 4mg*1 Tablet Followed by Daprodustat 2mg*2tablets | Daprodustat 4mg*1 (Fed) Followed by Daprodustat 4mg*1 (Fasted) | Daprodustat 4mg*1 (Fasted) Followed by Daprodustat 4mg*1(Fed) |
|---|---|---|---|---|
| TonsilitisInfections and infestations | 2/51 | 1/52 | 0/12 | 0/12 |
| NasopharyngitisInfections and infestations | 1/51 | 0/52 | 0/12 | 0/12 |
| PharyngitisInfections and infestations | 0/51 | 1/52 | 0/12 | 0/12 |
| Age, Continuous(Years) | Total Participants Part 1 | Total Participants Part 2 | Total |
|---|---|---|---|
| Mean | 27.9 ± 6.91 | 30.0 ± 7.51 | 28.3 ± 7.01 |
| Sex: Female, Male(Participants) | Total Participants Part 1 | Total Participants Part 2 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 52 | 12 | 64 |
| Race/Ethnicity, Customized(Participants) | Total Participants Part 1 | Total Participants Part 2 | Total |
|---|---|---|---|
| Asian -Japanese Heritage | 52 | 12 | 64 |
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 is available via the Clinical Study Data Request site (click on the link provided below)
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 Jun 2018, 1 month.
Results were first posted in Aug 2019, 1 year 1 month after primary completion.
Of 34 industry-sponsored phase 1 interventional studies under Anemia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's 1 month is below that.
Counting every sponsor, half of 48 studies reached it within 12 months; a quarter within 3 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK1278863