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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Preladenant

• Registration Number: NCT01323855
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study Start: 2011-03-28
• Study First Posted: 2011-03-28
• Primary Completion: 2011-11-29
• Study Completion: 2011-11-29
• Results First Submitted: 2016-02-11
• Results First Submitted QC: 2016-02-11
• Results First Posted: 2016-03-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive
• Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment)
• Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges
• Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions)

Exclusion Criteria

• Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
• Had a renal transplant or are on dialysis
• Has a history of any infectious disease within 4 weeks
• Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
• Has donated blood or had a blood transfusions in the past 60 days
• Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial
• Has a history of malignancy
• Has evidence of suicidality or is at risk for self-harm or harm to others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Severe Renal Impairment	Preladenant	Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Part 2: Moderate Renal Impairment	Preladenant	Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Part 2: Mild Renal Impairment	Preladenant	Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Part 2: Normal Renal Function	Preladenant	Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Part 1: Normal Renal Function	Preladenant	Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally

Primary Outcome Measures

Name	Time	Method
AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls	Pre-dose to 48 hours post-dose	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
AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls	Pre-dose to 48 hours post-dose	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
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	Pre-dose to 48 hours post-dose	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