Trials / Completed
CompletedNCT03493386
Daprodustat Bioequivalence and Food Effect Study
A Single Centre, Single Dose, Open-label, Randomised, 2-way Crossover Study in Healthy Japanese Male Subjects to Evaluate the Bioequivalence of Daprodustat Tablets (2 mg Tablet vs. 4 mg Tablet) (Part 1) and the Food Effect on the Pharmacokinetics of Daprodustat (Part 2)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses in healthy Japanese male subjects. This study will be conducted in two parts. Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner. There will 5-day wash-out period between each intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in Part 2. The study will last for 6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daprodustat 2 mg tablet | Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study. |
| DRUG | Daprodustat 4 mg tablet | Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study. |
Timeline
- Start date
- 2018-04-24
- Primary completion
- 2018-06-09
- Completion
- 2018-06-09
- First posted
- 2018-04-10
- Last updated
- 2020-07-08
- Results posted
- 2019-08-06
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03493386. Inclusion in this directory is not an endorsement.