drugset / Trial / NCT01323855

A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

NCT01323855

Phase 1 Completed 46 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-03-28
Primary completion
2011-11-29
Completion
2011-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Preladenant Small molecule 5 mg Oral

Indications