CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
Preladenantdrug
Likely dose
Preladenant 5 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/NCT01323855
NCT01323855Phase 1Completed
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A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment

Merck Sharp & Dohme LLC·interventional·Posted Mar 28, 2011·Updated Oct 2, 2018

In Brief

A Phase 1 clinical trial evaluating Preladenant for Parkinson Disease. Completed, enrolled 46 participants.

Detailed Summary

This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2011
Enrollment StartMar 28, 2011
Primary CompletionNov 29, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.3 years ago

Interventions

Preladenantdrug

After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally