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A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
odanacatib
Comparator: odanacatib (Panel B)
Comparator: odanacatib (Panel C)
Comparator: odanacatib (Panel D)
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 - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is in good health
  • Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
  • Female subject is postmenopausal
  • Subject is within 20% of ideal body weight
  • Subject is a nonsmoker

Exclusion Criteria:

  • Subject has multiple or severe allergies to food or medications
  • Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
  • Subject has any infections, including HIV
  • Subject consumes excessive amounts of caffeine or alcohol
  • Subject has donated blood or taken another investigational drug in the last month
  • Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    A

    B

    C

    D

    Arm Description

    Panel A

    Panel B

    Panel C

    Panel D

    Outcomes

    Primary Outcome Measures

    safety and tolerability based on assessment of clinical and laboratory adverse experiences

    Secondary Outcome Measures

    Plasma concentration of MK0822

    Full Information

    First Posted
    March 16, 2009
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00863590
    Brief Title
    A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers
    Official Title
    A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    August 2008 (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 assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

    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
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Panel A
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Panel B
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    Panel C
    Arm Title
    D
    Arm Type
    Experimental
    Arm Description
    Panel D
    Intervention Type
    Drug
    Intervention Name(s)
    odanacatib
    Intervention Description
    [Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: odanacatib (Panel B)
    Intervention Description
    Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: odanacatib (Panel C)
    Intervention Description
    Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: odanacatib (Panel D)
    Intervention Description
    Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.
    Primary Outcome Measure Information:
    Title
    safety and tolerability based on assessment of clinical and laboratory adverse experiences
    Time Frame
    Part I: 12 Weeks, Part II: 13 Weeks
    Secondary Outcome Measure Information:
    Title
    Plasma concentration of MK0822
    Time Frame
    Up to 336 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is in good health Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger Female subject is postmenopausal Subject is within 20% of ideal body weight Subject is a nonsmoker Exclusion Criteria: Subject has multiple or severe allergies to food or medications Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates Subject has any infections, including HIV Subject consumes excessive amounts of caffeine or alcohol Subject has donated blood or taken another investigational drug in the last month Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
    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
    23013236
    Citation
    Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
    Results Reference
    result

    Learn more about this trial

    A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

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