A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)

NCT ID: NCT01465412

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-10
• Study Completion Date: 2012-06-14

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].

Conditions

Chronic Hepatic Impairment

Study Design

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

Study Groups

Mild Hepatic Impaired (HI) Part 1

Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Healthy to Match Mild HI Part 1

Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.

Group Type: ACTIVE_COMPARATOR

Preladenant

Intervention Type: DRUG

After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Moderate HI Part 2

Participants with moderate chronic liver disease enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Healthy to Match Moderate HI Part 2

Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.

Group Type: ACTIVE_COMPARATOR

Preladenant

Intervention Type: DRUG

After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Interventions

Preladenant

After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.

Intervention Type: DRUG

Other Intervention Names

SCH 420814; MK-3814; Adenosine 2a Antagonist

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

MK-3814-034

Identifier Type: OTHER

Identifier Source: secondary_id

P06513

Identifier Type: -

Identifier Source: org_study_id