Trial Outcomes & Findings for Daprodustat Bioequivalence and Food Effect Study (NCT NCT03493386)
NCT ID: NCT03493386
Last Updated: 2020-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
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
Results posted on
2020-07-08
Participant Flow
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.
Total 64 healthy participants were enrolled in the study which was conducted from 24-April-18 to 09-June-18, study was conducted in two parts, Part 1 was the bioequivalence of daprodustat Tablets and part 2 was food effect on the pharmacokinetics (PK) of daprodustat.
Participant milestones
| Measure |
Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1
Participants received a single dose Daprodustat 2 milligram (mg) two tablets followed by Daprodustat 4 mg single tablet, administered orally on Day 1.There was a washout period of at least 5 days between the 2 intervention periods.
|
Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2
Participants received a single dose Daprodustat 4 mg one tablet followed by Daprodustat 2 mg two tablets, administered orally on Day 1. There was a washout period of at least 5 days between the 2 intervention periods.
|
Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast)
Participants received a single dose Daprodustat 4 mg one tablet in fed state followed by Daprodustat 4 mg one tablet as single dose in fasted state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
|
Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed)
Participants received a single dose Daprodustat 4 mg one tablet in fasted state followed by Daprodustat 4 mg one tablet as single dose in fed state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
|
|---|---|---|---|---|
|
Part 1, Intervention Period 1 (2 Days)
STARTED
|
26
|
26
|
0
|
0
|
|
Part 1, Intervention Period 1 (2 Days)
COMPLETED
|
26
|
26
|
0
|
0
|
|
Part 1, Intervention Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1, Washout Period (at Least 5 Days)
STARTED
|
26
|
26
|
0
|
0
|
|
Part 1, Washout Period (at Least 5 Days)
COMPLETED
|
26
|
25
|
0
|
0
|
|
Part 1, Washout Period (at Least 5 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Part 1, Intervention Period 2 (2 Days)
STARTED
|
26
|
25
|
0
|
0
|
|
Part 1, Intervention Period 2 (2 Days)
COMPLETED
|
26
|
25
|
0
|
0
|
|
Part 1, Intervention Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2, Intervention Period 1 (2 Days)
STARTED
|
0
|
0
|
6
|
6
|
|
Part 2, Intervention Period 1 (2 Days)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Part 2, Intervention Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2, Washout Period (at Least 5 Days)
STARTED
|
0
|
0
|
6
|
6
|
|
Part 2, Washout Period (at Least 5 Days)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Part 2, Washout Period (at Least 5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2, Intervention Period 2 (2 Days)
STARTED
|
0
|
0
|
6
|
6
|
|
Part 2, Intervention Period 2 (2 Days)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Part 2, Intervention Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Daprodustat 2mg*2+ Daprodustat 4mg*1
Participants received a single dose Daprodustat 2 milligram (mg) two tablets followed by Daprodustat 4 mg single tablet, administered orally on Day 1.There was a washout period of at least 5 days between the 2 intervention periods.
|
Part 1: Daprodustat 4mg*1 + Daprodustat 2mg*2
Participants received a single dose Daprodustat 4 mg one tablet followed by Daprodustat 2 mg two tablets, administered orally on Day 1. There was a washout period of at least 5 days between the 2 intervention periods.
|
Part 2: Daprodustat 4mg*1 (Fed) + Daprodustat 4mg*1 (Fast)
Participants received a single dose Daprodustat 4 mg one tablet in fed state followed by Daprodustat 4 mg one tablet as single dose in fasted state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
|
Part 2: Daprodustat 4mg*1 (Fast) + Daprodustat 4mg*1 (Fed)
Participants received a single dose Daprodustat 4 mg one tablet in fasted state followed by Daprodustat 4 mg one tablet as single dose in fed state, administered orally on Day 1.There was a washout period of at least 5 days between the 2 treatment periods.
|
|---|---|---|---|---|
|
Part 1, Washout Period (at Least 5 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Daprodustat Bioequivalence and Food Effect Study
Baseline characteristics by cohort
| Measure |
Total Participants Part 1
n=52 Participants
Participants received daprodustat 2mg\*2 tablets and daprodustat 4mg\*1 tablets (fasted state) in either of the two treatment periods separated by a washout of at least 5 days between the two treatment periods.
|
Total Participants Part 2
n=12 Participants
Participants received daprodustat 4mg\*1 tablet (fed state) and daprodustat 4mg\*1 tablet (fasted state) in either of the two treatment periods separated by a washout of at least 5 days between the two treatment periods.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.9 Years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
30.0 Years
STANDARD_DEVIATION 7.51 • n=7 Participants
|
28.3 Years
STANDARD_DEVIATION 7.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian -Japanese Heritage
|
52 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
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
AUC (0-inf)
|
183.0240 Hour*nanogram/milliliter
Geometric Coefficient of Variation 30.7
|
179.8710 Hour*nanogram/milliliter
Geometric Coefficient of Variation 30.4
|
|
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
AUC (0-t)
|
182.8420 Hour*nanogram/milliliter
Geometric Coefficient of Variation 30.7
|
179.6940 Hour*nanogram/milliliter
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Maximum Observed Drug Concentration (Cmax) of Daprodustat
|
88.8811 Nanogram/milliliter
Geometric Coefficient of Variation 37.0
|
85.1365 Nanogram/milliliter
Geometric Coefficient of Variation 37.0
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Terminal Phase Half-life (T1/2) of Daprodustat and Mean Residence Time (MRT)
t1/2
|
3.2427 hour
Geometric Coefficient of Variation 14.9
|
3.2579 hour
Geometric Coefficient of Variation 11.8
|
|
Part 1:Terminal Phase Half-life (T1/2) of Daprodustat and Mean Residence Time (MRT)
MRT
|
2.8142 hour
Geometric Coefficient of Variation 25.9
|
2.9637 hour
Geometric Coefficient of Variation 23.2
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Time of Occurrence of Cmax (Tmax) of Daprodustat
|
2.000 hour
Interval 1.0 to 4.0
|
2.000 hour
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Percentage of AUC (0-inf) Obtained by Extrapolation (Percentage AUCex)
|
0.0862 Percentage of AUCex
Geometric Coefficient of Variation 53.5
|
0.0836 Percentage of AUCex
Geometric Coefficient of Variation 55.3
|
PRIMARY outcome
Timeframe: 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 2Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Apparent Clearance (CL/F) of Daprodustat
|
21.8551 Liters per hour
Geometric Coefficient of Variation 30.7
|
22.2382 Liters per hour
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: 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 2Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Apparent Oral Volume of Distribution (Vz/F) of Daprodustat
|
102244.3 Milliliters (mL)
Geometric Coefficient of Variation 33.2
|
104522.8 Milliliters (mL)
Geometric Coefficient of Variation 30.8
|
PRIMARY outcome
Timeframe: 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 2Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Elimination Rate Constant (Kel) of Daprodustat
|
0.2138 Per hour
Geometric Coefficient of Variation 14.9
|
0.2128 Per hour
Geometric Coefficient of Variation 11.8
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2:AUC[0-t] andAUC [0-inf] of Daprodustat
AUC (0-inf)
|
143.1156 Hour*nanogram/milliliter
Geometric Coefficient of Variation 18.0
|
156.5481 Hour*nanogram/milliliter
Geometric Coefficient of Variation 19.2
|
|
Part 2:AUC[0-t] andAUC [0-inf] of Daprodustat
AUC (0-t)
|
142.9556 Hour*nanogram/milliliter
Geometric Coefficient of Variation 18.0
|
156.4222 Hour*nanogram/milliliter
Geometric Coefficient of Variation 19.3
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Cmax of Daprodustat
|
67.8240 Nanogram/milliliter (ng/L)
Geometric Coefficient of Variation 26.7
|
76.1944 Nanogram/milliliter (ng/L)
Geometric Coefficient of Variation 29.8
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: T1/2 and MRT of Daprodustat
t1/2
|
3.2160 hour
Geometric Coefficient of Variation 9.7
|
3.2389 hour
Geometric Coefficient of Variation 8.0
|
|
Part 2: T1/2 and MRT of Daprodustat
MRT
|
3.2420 hour
Geometric Coefficient of Variation 25.2
|
2.6695 hour
Geometric Coefficient of Variation 26.8
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Tmax of Daprodustat
|
2.750 hour
Interval 1.0 to 3.0
|
1.750 hour
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Percentage AUCex of Dapordustat
|
0.1071 Percentage of AUCex
Geometric Coefficient of Variation 30.9
|
0.0723 Percentage of AUCex
Geometric Coefficient of Variation 47.9
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: CL/F of Daprodustat
|
27.9494 Liters per hour
Geometric Coefficient of Variation 18.0
|
25.5512 Liters per hour
Geometric Coefficient of Variation 19.2
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Vz/F of Daprodustat
|
129676.9 Milliliters (mL)
Geometric Coefficient of Variation 18.7
|
119394.6 Milliliters (mL)
Geometric Coefficient of Variation 19.7
|
PRIMARY outcome
Timeframe: 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 2Population: PK Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Kel of Daprodustat
|
0.2155 Per hour
Geometric Coefficient of Variation 9.7
|
0.2140 Per hour
Geometric Coefficient of Variation 8.0
|
SECONDARY outcome
Timeframe: Up to Day 16Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
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.
Calcium 24hours
|
-0.016144 Millimoles per Liter (mmol/L)
Standard Deviation 0.0694710
|
-0.015834 Millimoles per Liter (mmol/L)
Standard Deviation 0.0623072
|
|
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.
Potassium 24hours
|
0.04 Millimoles per Liter (mmol/L)
Standard Deviation 0.295
|
0.03 Millimoles per Liter (mmol/L)
Standard Deviation 0.272
|
|
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.
Urea 24hours
|
-0.14000 Millimoles per Liter (mmol/L)
Standard Deviation 0.767902
|
-0.29178 Millimoles per Liter (mmol/L)
Standard Deviation 0.840240
|
|
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.
Glucose 24hours
|
-0.007619 Millimoles per Liter (mmol/L)
Standard Deviation 0.3094690
|
-0.004270 Millimoles per Liter (mmol/L)
Standard Deviation 0.3243933
|
|
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.
Cholesterol 24hours
|
-0.043607 Millimoles per Liter (mmol/L)
Standard Deviation 0.3197656
|
0.046747 Millimoles per Liter (mmol/L)
Standard Deviation 0.2952955
|
|
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.
Chloride 24hours
|
0.9 Millimoles per Liter (mmol/L)
Standard Deviation 1.74
|
0.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.63
|
|
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.
HDL cholesterol 24hours
|
-0.128793 Millimoles per Liter (mmol/L)
Standard Deviation 0.1230991
|
-0.111397 Millimoles per Liter (mmol/L)
Standard Deviation 0.1067511
|
|
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.
LDL cholesterol 24hours
|
0.022818 Millimoles per Liter (mmol/L)
Standard Deviation 0.2151606
|
0.099462 Millimoles per Liter (mmol/L)
Standard Deviation 0.2265669
|
|
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.
Phosphate 24hours
|
-0.102568 Millimoles per Liter (mmol/L)
Standard Deviation 0.1114273
|
-0.091281 Millimoles per Liter (mmol/L)
Standard Deviation 0.1110710
|
|
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.
Sodium 24hours
|
0.2 Millimoles per Liter (mmol/L)
Standard Deviation 1.37
|
0.0 Millimoles per Liter (mmol/L)
Standard Deviation 1.50
|
|
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.
Triglycerides 24hours
|
0.21802 Millimoles per Liter (mmol/L)
Standard Deviation 0.273901
|
0.16385 Millimoles per Liter (mmol/L)
Standard Deviation 0.274955
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
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).
ALP 24hours
|
-9.5 International unit per liter (IU/L)
Standard Deviation 17.24
|
-10.8 International unit per liter (IU/L)
Standard Deviation 12.83
|
|
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).
ALT 24hours
|
-2.0 International unit per liter (IU/L)
Standard Deviation 3.65
|
-1.0 International unit per liter (IU/L)
Standard Deviation 3.19
|
|
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).
AST 24hours
|
-2.1 International unit per liter (IU/L)
Standard Deviation 3.19
|
-1.8 International unit per liter (IU/L)
Standard Deviation 3.22
|
|
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).
Creatine kinase 24hours
|
-33.9 International unit per liter (IU/L)
Standard Deviation 28.73
|
-32.3 International unit per liter (IU/L)
Standard Deviation 30.24
|
|
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).
GGT 24hours
|
-1.6 International unit per liter (IU/L)
Standard Deviation 2.34
|
-1.1 International unit per liter (IU/L)
Standard Deviation 1.34
|
|
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).
Lactate dehydrogenase 24hours
|
-20.5 International unit per liter (IU/L)
Standard Deviation 12.30
|
-19.2 International unit per liter (IU/L)
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters; Albumin, Protein.
Albumin 24hours
|
-2.0 Grams per liter (g/L)
Standard Deviation 1.74
|
-2.0 Grams per liter (g/L)
Standard Deviation 1.69
|
|
Part 1: Change From Baseline in Chemistry Parameters; Albumin, Protein.
Protein 24hours
|
-2.3 Grams per liter (g/L)
Standard Deviation 2.90
|
-2.1 Grams per liter (g/L)
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Direct bilirubin 24hours
|
0.268 Micromoles per liter (umol/L)
Standard Deviation 0.7151
|
0.164 Micromoles per liter (umol/L)
Standard Deviation 0.6989
|
|
Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Bilirubin 24hours
|
2.615 Micromoles per liter (umol/L)
Standard Deviation 5.0537
|
2.960 Micromoles per liter (umol/L)
Standard Deviation 4.7784
|
|
Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Creatinine 24hours
|
1.7160 Micromoles per liter (umol/L)
Standard Deviation 4.18539
|
1.4110 Micromoles per liter (umol/L)
Standard Deviation 4.84901
|
|
Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Urate 24hours
|
26.1245 Micromoles per liter (umol/L)
Standard Deviation 28.30344
|
25.6222 Micromoles per liter (umol/L)
Standard Deviation 28.35581
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Change From Baseline in Hematology Parameter; Hematocrit
|
0.0005 Proportion of red blood cells in blood
Standard Deviation 0.01593
|
0.0014 Proportion of red blood cells in blood
Standard Deviation 0.01464
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1:Change From Baseline in Hematology Parameter; Reticulocytes
|
-0.0005 Praportion of reticulocytes in blood
Standard Deviation 0.00179
|
-0.0001 Praportion of reticulocytes in blood
Standard Deviation 0.00189
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters; Hemoglobin (Hb), Erythrocyte Mean Corpuscular Hb Concentration (MCHC)
Hb 24hours
|
1.1 Grams per Liter (g/L)
Standard Deviation 5.81
|
0.8 Grams per Liter (g/L)
Standard Deviation 4.99
|
|
Part 1: Change From Baseline in Hematology Parameters; Hemoglobin (Hb), Erythrocyte Mean Corpuscular Hb Concentration (MCHC)
MCHC 24hours
|
2.1 Grams per Liter (g/L)
Standard Deviation 4.23
|
0.8 Grams per Liter (g/L)
Standard Deviation 4.99
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Basophils 24hours
|
-0.01 Percentage of cells
Standard Deviation 0.173
|
0.00 Percentage of cells
Standard Deviation 0.197
|
|
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Eosinophils 24hours
|
0.27 Percentage of cells
Standard Deviation 0.871
|
0.25 Percentage of cells
Standard Deviation 0.874
|
|
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Lymphocytes 24hours
|
-1.47 Percentage of cells
Standard Deviation 6.070
|
-0.86 Percentage of cells
Standard Deviation 7.049
|
|
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Monocytes 24hours
|
-0.43 Percentage of cells
Standard Deviation 1.293
|
-0.33 Percentage of cells
Standard Deviation 1.108
|
|
Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Neutrophils 24hours
|
1.64 Percentage of cells
Standard Deviation 6.407
|
0.94 Percentage of cells
Standard Deviation 7.480
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter Erythrocyte MCHC
|
0.11 Picograms (pg)
Standard Deviation 0.331
|
0.01 Picograms (pg)
Standard Deviation 0.319
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter Erythrocyte Mean Corpuscular Volume (EMCV)
|
-0.2 Femtoliters
Standard Deviation 0.75
|
-0.2 Femtoliters
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Leukocytes 24hours
|
-0.55 Billion cells per liter (10^9/L)
Standard Deviation 0.883
|
-0.53 Billion cells per liter (10^9/L)
Standard Deviation 0.928
|
|
Part 1: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Platelets 24hours
|
0.7 Billion cells per liter (10^9/L)
Standard Deviation 13.21
|
2.0 Billion cells per liter (10^9/L)
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
|
0.018 Trillion cells/liter (10^12 cell/L)
Standard Deviation 0.1941
|
0.023 Trillion cells/liter (10^12 cell/L)
Standard Deviation 0.1771
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)
|
-0.04 pH
Standard Deviation 0.573
|
-0.07 pH
Standard Deviation 0.714
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24hours post-dosePopulation: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Urinalysis Parameter; Specific Gravity
|
0.0092 Kilogram per cubic meter
Standard Deviation 0.00744
|
0.0088 Kilogram per cubic meter
Standard Deviation 0.00767
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 3 and 24 hours (post-dose)Population: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP 3hours
|
-2.9 Millimeters of mercury (mmHg)
Standard Deviation 5.84
|
-1.5 Millimeters of mercury (mmHg)
Standard Deviation 7.00
|
|
Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP 24hours
|
-1.8 Millimeters of mercury (mmHg)
Standard Deviation 6.38
|
0.1 Millimeters of mercury (mmHg)
Standard Deviation 7.67
|
|
Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP 3hours
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.48
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 7.92
|
|
Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP 24hours
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 8.07
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 3 and 24 hours (post-dose)Population: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Pulse Rate
Pulse rate 3hours
|
0.0 Beats per minute
Standard Deviation 6.91
|
0.7 Beats per minute
Standard Deviation 4.78
|
|
Part 1: Change From Baseline in Pulse Rate
Pulse rate 24hours
|
0.1 Beats per minute
Standard Deviation 6.04
|
1.0 Beats per minute
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 3 and 24 hours (post-dose)Population: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Temperature
Temperature 3hours
|
0.23 Celcius (c)
Standard Deviation 0.256
|
0.22 Celcius (c)
Standard Deviation 0.311
|
|
Part 1: Change From Baseline in Temperature
Temperature 24hours
|
0.10 Celcius (c)
Standard Deviation 0.212
|
0.05 Celcius (c)
Standard Deviation 0.330
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 3 and 24 hours (post-dose)Population: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameter; Mean Heart Rate (HR)
Mean HR 3hours
|
0.6 Beats per minute
Standard Deviation 5.01
|
0.2 Beats per minute
Standard Deviation 4.21
|
|
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameter; Mean Heart Rate (HR)
Mean HR 24hours
|
1.2 Beats per minute
Standard Deviation 4.28
|
0.8 Beats per minute
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 3 and 24 hours (post-dose)Population: Safety Population.
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=51 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=52 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
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
QTcF interval, Aggregate 3hours
|
1.2 Milliseconds (msec)
Standard Deviation 14.98
|
1.6 Milliseconds (msec)
Standard Deviation 14.73
|
|
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
QtcF Interval, Aggregate 24hours
|
-2.4 Milliseconds (msec)
Standard Deviation 13.65
|
-3.1 Milliseconds (msec)
Standard Deviation 13.70
|
|
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
PR Interval, Aggregate 3hours
|
-3.3 Milliseconds (msec)
Standard Deviation 10.87
|
-3.8 Milliseconds (msec)
Standard Deviation 9.40
|
|
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
PR Interval, Aggregate 24hours
|
1.4 Milliseconds (msec)
Standard Deviation 8.13
|
0.0 Milliseconds (msec)
Standard Deviation 12.55
|
|
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
QRS Duration, Aggregate 3hours
|
-2.8 Milliseconds (msec)
Standard Deviation 6.50
|
-1.5 Milliseconds (msec)
Standard Deviation 6.42
|
|
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
QRS Duration, Aggregate 24hours
|
-1.6 Milliseconds (msec)
Standard Deviation 6.62
|
0.2 Milliseconds (msec)
Standard Deviation 6.50
|
|
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
QT interval, Aggregate 3hours
|
0.0 Milliseconds (msec)
Standard Deviation 20.31
|
0.8 Milliseconds (msec)
Standard Deviation 17.63
|
|
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
QT interval, Aggregate 24hours
|
-5.2 Milliseconds (msec)
Standard Deviation 17.42
|
-5.3 Milliseconds (msec)
Standard Deviation 18.33
|
SECONDARY outcome
Timeframe: Up to Day 16Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Sodium, 24hours
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.35
|
0.9 Millimoles per Liter (mmol/L)
Standard Deviation 1.38
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Glucose, 24hours
|
-0.425577 Millimoles per Liter (mmol/L)
Standard Deviation 0.2902134
|
-0.018503 Millimoles per Liter (mmol/L)
Standard Deviation 0.2530908
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Calcium, 24hours
|
-0.076929 Millimoles per Liter (mmol/L)
Standard Deviation 0.0515273
|
-0.058217 Millimoles per Liter (mmol/L)
Standard Deviation 0.0595515
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Cholesterol, 24hours
|
-0.172400 Millimoles per Liter (mmol/L)
Standard Deviation 0.2567913
|
-0.094820 Millimoles per Liter (mmol/L)
Standard Deviation 0.2225472
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Chloride, 24hours
|
1.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.45
|
2.1 Millimoles per Liter (mmol/L)
Standard Deviation 2.27
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
HDL cholesterol, 24hours
|
-0.165935 Millimoles per Liter (mmol/L)
Standard Deviation 0.0995210
|
-0.148695 Millimoles per Liter (mmol/L)
Standard Deviation 0.0826086
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
LDL cholesterol, 24hours
|
-0.170245 Millimoles per Liter (mmol/L)
Standard Deviation 0.1823445
|
-0.066805 Millimoles per Liter (mmol/L)
Standard Deviation 0.1724049
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Potassium, 24hours
|
0.06 Millimoles per Liter (mmol/L)
Standard Deviation 0.294
|
0.19 Millimoles per Liter (mmol/L)
Standard Deviation 0.231
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Phosphate, 24hours
|
-0.029599 Millimoles per Liter (mmol/L)
Standard Deviation 0.0928311
|
-0.080725 Millimoles per Liter (mmol/L)
Standard Deviation 0.1324212
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Triglycerides, 24hours
|
0.25331 Millimoles per Liter (mmol/L)
Standard Deviation 0.219827
|
0.08475 Millimoles per Liter (mmol/L)
Standard Deviation 0.197228
|
|
Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea
Urea, 24hours
|
0.19040 Millimoles per Liter (mmol/L)
Standard Deviation 0.552713
|
-0.14875 Millimoles per Liter (mmol/L)
Standard Deviation 0.588353
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
ALP, 24hours
|
-18.9 International unit per liter (IU/L)
Standard Deviation 15.48
|
-13.3 International unit per liter (IU/L)
Standard Deviation 10.54
|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
ALT, 24hours
|
-3.1 International unit per liter (IU/L)
Standard Deviation 2.43
|
-3.5 International unit per liter (IU/L)
Standard Deviation 2.02
|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
AST, 24hours
|
-2.8 International unit per liter (IU/L)
Standard Deviation 2.18
|
-2.7 International unit per liter (IU/L)
Standard Deviation 2.46
|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
Creatine kinase, 24hours
|
-28.3 International unit per liter (IU/L)
Standard Deviation 13.70
|
-15.3 International unit per liter (IU/L)
Standard Deviation 17.56
|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
Lactate dehydrogenase, 24hours
|
-21.0 International unit per liter (IU/L)
Standard Deviation 9.68
|
-18.4 International unit per liter (IU/L)
Standard Deviation 9.05
|
|
Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT
GGT, 24hours
|
-1.0 International unit per liter (IU/L)
Standard Deviation 1.41
|
-1.6 International unit per liter (IU/L)
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters; Albumin, Protein
Albumin 24hours
|
-3.2 Grams per liter (g/L)
Standard Deviation 1.34
|
-1.9 Grams per liter (g/L)
Standard Deviation 1.16
|
|
Part 2: Change From Baseline in Chemistry Parameters; Albumin, Protein
Protein 24hours
|
-3.4 Grams per liter (g/L)
Standard Deviation 2.94
|
-2.6 Grams per liter (g/L)
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Direct bilirubin, 24hours
|
0.000 Micromoles per liter (umol/L)
Standard Deviation 0.000
|
0.000 Micromoles per liter (umol/L)
Standard Deviation 1.0312
|
|
Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Bilirubin, 24hours
|
2.280 Micromoles per liter (umol/L)
Standard Deviation 5.2748
|
1.425 Micromoles per liter (umol/L)
Standard Deviation 3.1643
|
|
Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Creatinine, 24hours
|
-1.6207 Micromoles per liter (umol/L)
Standard Deviation 5.16603
|
-1.1050 Micromoles per liter (umol/L)
Standard Deviation 5.68072
|
|
Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate
Urate, 24hours
|
23.2963 Micromoles per liter (umol/L)
Standard Deviation 20.98470
|
21.8093 Micromoles per liter (umol/L)
Standard Deviation 19.53615
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters; Hematocrit
|
-0.0052 Praportion of red blood cells in blood
Standard Deviation 0.01629
|
-0.0025 Praportion of red blood cells in blood
Standard Deviation 0.01519
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters; Reticulocytes
|
-0.0002 Praportion of reticulocytes in blood
Standard Deviation 0.00164
|
-0.0010 Praportion of reticulocytes in blood
Standard Deviation 0.00186
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters; Hb, Erythrocyte MCHC
EMCH concentration 24hours
|
0.4 Grams per liter (g/L)
Standard Deviation 5.55
|
-0.6 Grams per liter (g/L)
Standard Deviation 4.66
|
|
Part 2: Change From Baseline in Hematology Parameters; Hb, Erythrocyte MCHC
Hb 24hours
|
-2.1 Grams per liter (g/L)
Standard Deviation 5.28
|
-1.2 Grams per liter (g/L)
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Basophils, 24hours
|
-0.04 Percentage of cells
Standard Deviation 0.193
|
-0.17 Percentage of cells
Standard Deviation 0.239
|
|
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Eosinophils, 24hours
|
0.62 Percentage of cells
Standard Deviation 1.620
|
-0.49 Percentage of cells
Standard Deviation 0.312
|
|
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Lymphocytes, 24hours
|
-2.31 Percentage of cells
Standard Deviation 3.815
|
-1.14 Percentage of cells
Standard Deviation 6.015
|
|
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Monocytes, 24hours
|
-0.38 Percentage of cells
Standard Deviation 0.732
|
-0.03 Percentage of cells
Standard Deviation 1.414
|
|
Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils
Neutrophils, 24hours
|
2.12 Percentage of cells
Standard Deviation 5.072
|
1.83 Percentage of cells
Standard Deviation 5.829
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: EMCH
|
0.10 picograms
Standard Deviation 0.413
|
0.03 picograms
Standard Deviation 0.311
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter EMCV
|
0.5 Femtoliters
Standard Deviation 0.67
|
0.3 Femtoliters
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Platelets, 24hours
|
-10.9 Billion cells per liter (10^9/L)
Standard Deviation 11.19
|
-3.2 Billion cells per liter (10^9/L)
Standard Deviation 12.04
|
|
Part 2: Change From Baseline in Hematology Parameters Platelets, Leukocytes
Leukocytes, 24hours
|
-0.27 Billion cells per liter (10^9/L)
Standard Deviation 0.780
|
-0.39 Billion cells per liter (10^9/L)
Standard Deviation 0.579
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter Erythrocytes
|
-0.083 Trillion cells/liter (10^12 cell/L)
Standard Deviation 0.1859
|
-0.044 Trillion cells/liter (10^12 cell/L)
Standard Deviation 0.1767
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)
|
0.13 pH
Standard Deviation 0.433
|
0.13 pH
Standard Deviation 0.608
|
SECONDARY outcome
Timeframe: Baseline (Day -1), 24 hours (post-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Urinalysis Parameter; Specific Gravity
|
0.0054 Kilogram per cubic meter
Standard Deviation 0.01215
|
0.0013 Kilogram per cubic meter
Standard Deviation 0.00900
|
SECONDARY outcome
Timeframe: Baseline (Day -1),3 and 24hours (pre-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 24hours
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.14
|
2.8 Millimeters of mercury (mmHg)
Standard Deviation 6.97
|
|
Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 3hours
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 6.10
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 8.41
|
|
Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 24hours
|
1.4 Millimeters of mercury (mmHg)
Standard Deviation 6.93
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 5.18
|
|
Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 3hours
|
-4.8 Millimeters of mercury (mmHg)
Standard Deviation 4.90
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: Baseline (Day -1),3 and 24hours (pre-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Pulse Rate
Pulse rate, 3hours
|
6.1 Beats per minute
Standard Deviation 5.37
|
-1.5 Beats per minute
Standard Deviation 5.82
|
|
Part 2: Change From Baseline in Pulse Rate
Pulse rate, 24hours
|
4.0 Beats per minute
Standard Deviation 5.24
|
2.9 Beats per minute
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Baseline (Day -1),3 and 24hours (pre-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in Temperature
Temperature, 3hours
|
0.28 celcius
Standard Deviation 0.302
|
0.13 celcius
Standard Deviation 0.293
|
|
Part 2: Change From Baseline in Temperature
Temperature, 24hours
|
0.02 celcius
Standard Deviation 0.424
|
0.03 celcius
Standard Deviation 0.245
|
SECONDARY outcome
Timeframe: Baseline (Day -1),3 and 24hours (pre-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in ECG Parameter; Mean Heart Rate (HR)
Mean HR, 3hours
|
3.7 Beats/minute
Standard Deviation 6.18
|
0.0 Beats/minute
Standard Deviation 4.07
|
|
Part 2: Change From Baseline in ECG Parameter; Mean Heart Rate (HR)
Mean HR, 24hours
|
3.1 Beats/minute
Standard Deviation 6.60
|
0.6 Beats/minute
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: Baseline (Day -1),3 and 24hours (pre-dose)Population: Safety Population
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.
Outcome measures
| Measure |
Part 1: Daprodustat 2mg*2
n=12 Participants
Participants received a single dose of daprodustat 2mg\*2 tablets, administered orally in fasted state on Day 1 in either of period 1 and Period 2 as per the randomization schedule
|
Part 1: Daprodustat 4mg*1
n=12 Participants
Participants received single dose of Daprodustat 4mg one tablet, administered orally in fasted state on Day 1 in either of Period 1 and Period 2 as per randomization schedule
|
|---|---|---|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
PR Interval, Aggregate, 3hours
|
-6.2 Milliseconds (msec)
Standard Deviation 6.00
|
-2.7 Milliseconds (msec)
Standard Deviation 9.55
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
PR Interval, Aggregate, 24hours
|
-4.0 Milliseconds (msec)
Standard Deviation 7.53
|
-3.2 Milliseconds (msec)
Standard Deviation 7.11
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QRS Duration, Aggregate, 3hours
|
-1.5 Milliseconds (msec)
Standard Deviation 4.52
|
-0.5 Milliseconds (msec)
Standard Deviation 5.13
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QRS Duration, Aggregate, 24hours
|
-0.8 Milliseconds (msec)
Standard Deviation 4.39
|
2.8 Milliseconds (msec)
Standard Deviation 7.93
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QT interval, Aggregate, 3hours
|
-13.0 Milliseconds (msec)
Standard Deviation 15.81
|
1.0 Milliseconds (msec)
Standard Deviation 16.28
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QT Interval, Aggregate, 24hours
|
-7.3 Milliseconds (msec)
Standard Deviation 13.73
|
-2.2 Milliseconds (msec)
Standard Deviation 12.34
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QTcF Interval, Aggregate, 3hours
|
-5.3 Milliseconds (msec)
Standard Deviation 11.93
|
1.2 Milliseconds (msec)
Standard Deviation 13.64
|
|
Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval
QTcF Interval, Aggregate, 24hours
|
-0.6 Milliseconds (msec)
Standard Deviation 12.87
|
-1.1 Milliseconds (msec)
Standard Deviation 9.69
|
Adverse Events
Daprodustat 2mg*2 Followed by Daprodustat 4mg*1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Daprodustat 4mg*1 Tablet Followed by Daprodustat 2mg*2tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Daprodustat 4mg*1 (Fed) Followed by Daprodustat 4mg*1 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daprodustat 4mg*1 (Fasted) Followed by Daprodustat 4mg*1(Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daprodustat 2mg*2 Followed by Daprodustat 4mg*1
n=51 participants at risk
Participants received a single dose Daprodustat 2 milligram (mg) two tablets followed by Daprodustat 4 mg single tablet, administered orally on Day 1.
|
Daprodustat 4mg*1 Tablet Followed by Daprodustat 2mg*2tablets
n=52 participants at risk
Participants received a single dose Daprodustat 4 mg one tablet followed by Daprodustat 2 mg two tablets, administered orally on Day 1.
|
Daprodustat 4mg*1 (Fed) Followed by Daprodustat 4mg*1 (Fasted)
n=12 participants at risk
Participants received a single dose Daprodustat 4 mg one tablet in fed state followed by Daprodustat 4 mg one tablet as single dose in fasted state, administered orally on Day 1.
|
Daprodustat 4mg*1 (Fasted) Followed by Daprodustat 4mg*1(Fed)
n=12 participants at risk
Participants received a single dose Daprodustat 4 mg one tablet in fasted state followed by Daprodustat 4 mg one tablet as single dose in fed state, administered orally on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Tonsilitis
|
3.9%
2/51 • Number of events 2 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
1.9%
1/52 • Number of events 1 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/52 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/51 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
1.9%
1/52 • Number of events 1 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
0.00%
0/12 • AEs and SAEs were collected from the Day -1 up to follow-up ( 16 days for Part 1 and Part 2)
Safety Population was used. Safety Population comprised of all participants who received at least one dose of a study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER