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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preladenant

Drug

After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally

Other names: SCH 420814

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

Time frame: 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 Moderate CRI Versus Healthy Matched Controls

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Mar 28, 2011
Registry last updated: Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed