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Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

Primary Purpose

Osteoporosis

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

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
  • Females must be past menopause
  • Subject is a nonsmoker
  • Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
  • Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion Criteria:

  • Subject has a history of multiple/severe allergies to drugs or food
  • Subject has donated blood within 4 weeks of starting the study
  • Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
  • Subject has any infections or any condition leading to immune problems, including HIV
  • Subject regularly uses illegal drugs
  • Subject consumes more than 3 alcoholic beverages per day
  • Subject drinks 4 or more caffeinated beverages per day
  • Subject uses any prescription or nonprescription medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    odanacatib (MK0822)

    placebo to odanacatib (MK0822)

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of multiple oral doses of MK0822

    Secondary Outcome Measures

    PK profile of MK0822

    Full Information

    First Posted
    October 6, 2008
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00769418
    Brief Title
    Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
    Official Title
    A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    odanacatib (MK0822)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    placebo to odanacatib (MK0822)
    Intervention Type
    Drug
    Intervention Name(s)
    odanacatib
    Other Intervention Name(s)
    MK0822
    Intervention Description
    Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: odanacatib tablets 2.5 mg qd for 14 days. Panel B: odanacatib tablets 5 mg qd for 14 days. Panel C: odanacatib tablets 10 mg qd for 14 days. Panel D: odanacatib tablets 25 mg qd for 14 days. Panel E: odanacatib tablets 0.5 mg qd for 21 days. Panel F: odanacatib tablets 2.5 mg qd for 21 days. Panel G: odanacatib tablets 10 mg qd for 21 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days. Panel B: placebo to odanacatib tablets 5 mg qd for 14 days. Panel C: placebo to odanacatib tablets 10 mg qd for 14 days. Panel D: placebo to odanacatib tablets 25 mg qd for 14 days. Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days. Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days. Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of multiple oral doses of MK0822
    Time Frame
    After 14 days of treatment for men and 21 days for women
    Secondary Outcome Measure Information:
    Title
    PK profile of MK0822
    Time Frame
    predose and at selected time intervals postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age Females must be past menopause Subject is a nonsmoker Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling Subject is willing to refrain from consuming grapefruit or grapefruit juice Exclusion Criteria: Subject has a history of multiple/severe allergies to drugs or food Subject has donated blood within 4 weeks of starting the study Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment Subject has any infections or any condition leading to immune problems, including HIV Subject regularly uses illegal drugs Subject consumes more than 3 alcoholic beverages per day Subject drinks 4 or more caffeinated beverages per day Subject uses any prescription or nonprescription medications
    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

    Citations:
    PubMed Identifier
    19421185
    Citation
    Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.
    Results Reference
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    Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

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