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NCT02412449 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
A Phase 1 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02412449: Completed Phase 1 study, sponsored by Akebia Therapeutics.
NCT02412449 is a Phase 1 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02412449, a Phase 1 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.
Interventions
- DRUG AKB-6548 tablet, reference formulation given in the fasted state
- DRUG AKB-6548 tablet, test formulation given in the fasted state.
- DRUG AKB-6548 tablet, test formulation given in the fed state
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT02412449 record still lists
NCT02412449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which AKB-6548 tablet, reference formulation given in the fasted state is the first listed.
NCT02412449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02412449 about?
NCT02412449 is a clinical study titled "Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects". The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulati...
What is the current status of trial NCT02412449?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02412449?
The interventions under investigation include: AKB-6548 tablet, reference formulation given in the fasted state (DRUG), AKB-6548 tablet, test formulation given in the fasted state. (DRUG), AKB-6548 tablet, test formulation given in the fed state (DRUG).
Who is sponsoring clinical trial NCT02412449?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02412449's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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