Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1326
Source ID: NCT01323855
Associated Drug: Preladenant
Title: A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01323855/results
Conditions: Parkinson Disease
Interventions: DRUG: Preladenant
Outcome Measures: Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls, Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant, Pre-dose to 48 hours post-dose|AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls, Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant, Pre-dose to 48 hours post-dose|AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls, Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant, Pre-dose to 48 hours post-dose |
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-03-28
Completion Date: 2011-11-29
Results First Posted: 2016-03-10
Last Update Posted: 2018-10-02
Locations:
URL: https://clinicaltrials.gov/show/NCT01323855