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

Merck Sharp & Dohme LLC46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Pre-dose to 48 hours post-dose