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.
A Single Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Hepatic Insufficiency
In Brief
A Phase 1 clinical trial evaluating Suvorexant for Insomnia and Hepatic Insufficiency. Completed, enrolled 16 participants.
Detailed Summary
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Hepatic Insufficiency
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartFeb 2010
Primary CompletionApr 2010
TodayJul 2026
First PostedJan 7, 2010
Enrollment StartFeb 22, 2010
Primary CompletionApr 14, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.5 years ago
Interventions
Suvorexantdrug
single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.