A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1: Severe Renal Impairment
Part 2: Moderate Renal Impairment
Part 2: Mild Renal Impairment
Part 1: Normal Renal Function
Part 2: Normal Renal Function
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
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
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
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
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