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

A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment

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 Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Preladenant

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Severe Renal Impairment; 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	Drug: Preladenant; After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally; Other Names: SCH 420814
Experimental: Part 2: Moderate Renal Impairment; 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	Drug: Preladenant; After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally; Other Names: SCH 420814
Experimental: Part 2: Mild Renal Impairment; 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	Drug: Preladenant; After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally; Other Names: SCH 420814
Experimental: Part 1: Normal Renal Function; 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	Drug: Preladenant; After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally; Other Names: SCH 420814
Experimental: Part 2: Normal Renal Function; 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	Drug: Preladenant; After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally; Other Names: SCH 420814

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2011
• Primary Completion (Actual): November 29, 2011
• Study Completion (Actual): November 29, 2011

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 28, 2011

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Renal Insufficiency, Chronic; Parkinson Disease
• Other Study ID Numbers: P06512; 2010-023063-18 (EudraCT Number); MK-3814-031 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf