Clinical trial NCT01465412: A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Official title: An Open-label, Single Dose, Oral Administration, Sequential Two Parts Study to Compare the Pharmacokinetics of SCH 420814 / MK-3814 in Subjects With Mild and Moderate Chronic Hepatic Impairment With Their Respectively Matching Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatic Impairment
Keywords: Parkinson disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval \[0.50, 2.00\].


Eligibility criteria: Key Inclusion Criteria for Healthy Participants Groups:

* Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

* Must have mild or moderate hepatic impairment.
* Must have a diagnosis of chronic liver disease for \>6 months.
* Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
* Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

* Must not be on any prohibited medications for entry into the trial.

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
Secondary outcomes:
measure: AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
measure: Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant
timeFrame: Pre-dose up to 72 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: