Trials / Completed
CompletedNCT03108924
The Pharmacokinetics of Gefapixant (MK-7264) in Participants With Renal Insufficiency (MK-7264-026)
An Open-Label, Single-Dose Study to Investigate the Influence of Renal Insufficiency on the Pharmacokinetics of MK-7264
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This trial aims to evaluate the plasma pharmacokinetics of gefapixant (MK-7264) administered to participants with varying degrees of renal insufficiency (RI) compared to healthy matched controls; and to investigate the extent of MK-7264 removal by hemodialysis (HD) in participants with end stage renal disease (ESRD), following administration of a single 50 mg dose of gefapixant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gefapixant | After an overnight fast participants receive a single oral dose of 50 mg gefapixant, in one 50 mg tablet. |
Timeline
- Start date
- 2017-04-14
- Primary completion
- 2017-09-03
- Completion
- 2017-09-13
- First posted
- 2017-04-11
- Last updated
- 2022-07-27
- Results posted
- 2019-08-02
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03108924. Inclusion in this directory is not an endorsement.