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

NCT01465412 | Completed Phase 1 Results

• 2 other identifiers: P06513MK-3814-034
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Keywords

Parkinson disease

Outcome Measures

Primary Outcomes (2)

• 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

  For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.

  Pre-dose up to 72 hours postdose

• Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant

  For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.

  Pre-dose up to 72 hours postdose

Secondary Outcomes (6)

• AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant

  Pre-dose up to 72 hours postdose

• Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant

  Pre-dose up to 72 hours postdose

• AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant

  Pre-dose up to 72 hours postdose

• Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant

  Pre-dose up to 72 hours postdose

• AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant

  Pre-dose up to 72 hours postdose

Study Arms (4)

Mild Hepatic Impaired (HI) Part 1

EXPERIMENTAL

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

Drug: Preladenant

Healthy to Match Mild HI Part 1

ACTIVE COMPARATOR

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.

Drug: Preladenant

Moderate HI Part 2

EXPERIMENTAL

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

Drug: Preladenant

Healthy to Match Moderate HI Part 2

ACTIVE COMPARATOR

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.

Drug: Preladenant

Interventions

Preladenant DRUG

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

Also known as: SCH 420814, MK-3814, Adenosine 2a Antagonist

Healthy to Match Mild HI Part 1; Healthy to Match Moderate HI Part 2; Mild Hepatic Impaired (HI) Part 1; Moderate HI Part 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 4, 2011
• Study Start: November 10, 2011
• Primary Completion: June 14, 2012
• Study Completion: June 14, 2012
• Last Updated: September 24, 2018
• Results First Posted: April 6, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share