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NCT04640311 · ClinicalTrials.gov registry record · Phase 1
Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 259
- Enrollment target
NCT04640311: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT04640311 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 259 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (332% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640311, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 259 participants
- Enrollment target
Study Summary
This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There will be a minimum of a 7-day washout period between treatment periods. Participants will participate in Part A or Part B, but not both. Approximately 200 participants will be included in the study.
Primary Outcome
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Interventions
- DRUG Daprodustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2021-05-18 |
| Phase | Phase 1 |
What the finished NCT04640311 record still lists
NCT04640311 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (332% higher).
The record links to 0 conditions, and to 1 intervention - of which Daprodustat is the first listed.
NCT04640311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04640311 about?
NCT04640311 is a clinical study titled "Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants". This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There will be a minimum of a 7-day washout period between treatment periods. Participants will participate in Part A or Part ...
What is the current status of trial NCT04640311?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 259 participants. The study started on 2020-12-18. Estimated completion is 2021-05-18.
What interventions are being tested in trial NCT04640311?
The interventions under investigation include: Daprodustat (DRUG).
Who is sponsoring clinical trial NCT04640311?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04640311's enrollment target sits among peer trials
259 167th of 2000 higher than 1,834 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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