Clinical trial NCT01323855: A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Official title: A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Pre-dose to 48 hours post-dose
measure: AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
timeFrame: Pre-dose to 48 hours post-dose
measure: AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls
timeFrame: Pre-dose to 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: