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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatic Impairment

Treatments: Drug: Preladenant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465412

P06513

MK-3814-034 (Other Identifier)

Details and patient eligibility

About

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].

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

Mild Hepatic Impaired (HI) Part 1

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Healthy to Match Mild HI Part 1

Active Comparator group

Description:

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.

Treatment:

Drug: Preladenant

Moderate HI Part 2

Experimental group

Description:

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

Treatment:

Drug: Preladenant

Healthy to Match Moderate HI Part 2

Active Comparator group

Description:

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.

Treatment:

Drug: Preladenant