At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
MK-0822drug
Likely dose
MK-0822 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.
A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal Insufficiency
In Brief
A Phase 1 clinical trial evaluating MK-0822 for Renal Insufficiency. Completed, enrolled 25 participants.
Detailed Summary
This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionAug 2012
TodayJul 2026
First PostedJan 19, 2012
Enrollment StartJan 17, 2012
Primary CompletionAug 22, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago
Interventions
MK-0822drug
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.