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Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)

Primary Purpose

Healthy Volunteers, Hepatic Insufficiency

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ridaforolimus
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring Healthy Volunteers, Hepatic Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Hepatic Patients:

  • Female patient is of non-child bearing potential
  • Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
  • Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis

Healthy Subjects:

  • Female subject is of non-childbearing potential
  • Subject is in good health

Exclusion Criteria:

Hepatic Patients and Healthy Subjects:

  • Works a night shift and is not able to avoid night shift work during the study
  • Has a history of stroke, seizure or major neurological disease
  • Has a history of cancer
  • Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
  • Consumes excessive amounts of alcohol or caffeine
  • Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients with Moderate Hepatic Insufficiency

    Healthy Control Subjects

    Arm Description

    Patients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus.

    Healthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of ridaforolimus.

    Outcomes

    Primary Outcome Measures

    Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
    Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
    Tmax of a Single Oral Dose of Ridaforolimus.
    Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2010
    Last Updated
    April 28, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01043887
    Brief Title
    Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)
    Official Title
    A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Ariad Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy Volunteers, Hepatic Insufficiency
    Keywords
    Healthy Volunteers, Hepatic Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with Moderate Hepatic Insufficiency
    Arm Type
    Experimental
    Arm Description
    Patients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus.
    Arm Title
    Healthy Control Subjects
    Arm Type
    Experimental
    Arm Description
    Healthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of ridaforolimus.
    Intervention Type
    Drug
    Intervention Name(s)
    ridaforolimus
    Intervention Description
    single oral dose administration 10 mg ridaforolimus
    Primary Outcome Measure Information:
    Title
    Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
    Time Frame
    288 hours postdose
    Title
    Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
    Time Frame
    288 hours postdose
    Title
    Tmax of a Single Oral Dose of Ridaforolimus.
    Time Frame
    288 hours postdose
    Title
    Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.
    Time Frame
    288 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hepatic Patients: Female patient is of non-child bearing potential Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis Healthy Subjects: Female subject is of non-childbearing potential Subject is in good health Exclusion Criteria: Hepatic Patients and Healthy Subjects: Works a night shift and is not able to avoid night shift work during the study Has a history of stroke, seizure or major neurological disease Has a history of cancer Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study Consumes excessive amounts of alcohol or caffeine Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)

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