At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Gefapixantdrug
Likely dose
Gefapixant 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Study to Investigate the Influence of Renal Insufficiency on the Pharmacokinetics of MK-7264
In Brief
A Phase 1 clinical trial evaluating Gefapixant for Renal Insufficiency. Completed, enrolled 24 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartApr 2017
Primary CompletionSep 2017
Study CompletionSep 2017
TodayJul 2026
First PostedApr 11, 2017
Enrollment StartApr 14, 2017
Primary CompletionSep 3, 2017
Study CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.2 years ago
Interventions
Gefapixantdrug
After an overnight fast participants receive a single oral dose of 50 mg gefapixant, in one 50 mg tablet.