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

• Status: Completed
• Trial end date: 2011-11-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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