CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 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.

Search/NCT01512693
NCT01512693Phase 1Completed
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Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Hepatic Insufficiency

Merck Sharp & Dohme LLC·interventional·Posted Jan 19, 2012·Updated Aug 29, 2018

In Brief

A Phase 1 clinical trial evaluating MK-0822 for Hepatic Insufficiency. Completed, enrolled 17 participants.

Detailed Summary

This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2012
Enrollment StartFeb 23, 2012
Primary CompletionApr 24, 2012
TodayJul 2, 2026
Enrollment to primary: 2 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.