Trials / Completed
CompletedNCT02502500
Effect of AKB-6548 on the Pharmacokinetics of Celecoxib
An Open-label Study in Healthy Subjects to Assess the Effect of Once-daily Multiple Dosing of AKB-6548 on the Pharmacokinetics of the CYP2C9 Substrate Celecoxib
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Akebia Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
Detailed description
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Celecoxib | |
| DRUG | AKB-6548 |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2015-07-01
- Completion
- 2015-09-01
- First posted
- 2015-07-20
- Last updated
- 2018-11-14
Source: ClinicalTrials.gov record NCT02502500. Inclusion in this directory is not an endorsement.