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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Preladenant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323855

2010-023063-18 (EudraCT Number)

MK-3814-031 (Other Identifier)

P06512

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 5 patient groups

Part 1: Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Part 2: Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Part 2: Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Part 1: Normal Renal Function

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Part 2: Normal Renal Function

Experimental group

Description:

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

Treatment:

Drug: Preladenant