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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Preladenant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Severe Renal Impairment<br>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<br>* After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally<br>* Other names: SCH 420814;|
| Experimental: Part 2: Moderate Renal Impairment<br>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<br>* After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally<br>* Other names: SCH 420814;|
| Experimental: Part 2: Mild Renal Impairment<br>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<br>* After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally<br>* Other names: SCH 420814;|
| Experimental: Part 1: Normal Renal Function<br>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<br>* After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally<br>* Other names: SCH 420814;|
| Experimental: Part 2: Normal Renal Function<br>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<br>* After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally<br>* Other names: SCH 420814;|

What is the study measuring?
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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 |