At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Suvorexantdrug
Likely dose
Suvorexant 20 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 Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function
In Brief
A Phase 1 clinical trial evaluating Suvorexant for Insomnia. Completed, enrolled 16 participants.
Detailed Summary
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMay 2010
Primary CompletionJul 2010
TodayJul 2026
First PostedFeb 1, 2010
Enrollment StartMay 24, 2010
Primary CompletionJul 15, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.4 years ago
Interventions
Suvorexantdrug
single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \~240 mL of water after an 8 hour fast