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Completed

NCT Number: NCT01465412

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

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].

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Key information

Conditions

Chronic Hepatic Impairment Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preladenant

Drug

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

Other names: SCH 420814, MK-3814, Adenosine 2a Antagonist

Primary outcomes

  1. 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

    Time frame: Pre-dose up to 72 hours postdose

    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.

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

    Time frame: Pre-dose up to 72 hours postdose

    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.

Secondary outcomes

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

    Time frame: Pre-dose up to 72 hours postdose

    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 SCH 434748.

  2. Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant

    Time frame: Pre-dose up to 72 hours postdose

    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 SCH 434748.

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

    Time frame: Pre-dose up to 72 hours postdose

    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 SCH 446637.

  4. Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant

    Time frame: Pre-dose up to 72 hours postdose

    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 SCH 446637.

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

    Time frame: Pre-dose up to 72 hours postdose

    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 calculated using free drug concentration.

  6. Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant

    Time frame: Pre-dose up to 72 hours postdose

    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 calculated using free drug concentration.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2011
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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