Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 18 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02412449
The ClinicalTrials.gov registry entry for NCT02412449 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akebia Therapeutics, which has 24 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.