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

NCT ID: NCT01323855

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-28
• Study Completion Date: 2011-11-29

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

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

Interventions

Preladenant

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

Intervention Type: DRUG

Other Intervention Names

SCH 420814

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2010-023063-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-3814-031

Identifier Type: OTHER

Identifier Source: secondary_id

P06512

Identifier Type: -

Identifier Source: org_study_id