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A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
odanacatib
Comparator: placebo to MK0822
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 - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is less than or equal to 75 years of age
  • Subject is a postmenopausal female
  • Subject is within 30% of ideal body weight
  • Subject is judged to be in good health
  • Subject is a nonsmoker
  • Subject is willing to avoid excessive alcohol consumption for the duration of the study
  • Subject is willing to avoid strenuous physical activity for the duration of the study
  • Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study

Exclusion Criteria:

  • Subject has a history of multiple/severe allergies to foods or drugs
  • Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
  • Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
  • Subject has a history of bone disease or treatment with bisphosphonates
  • Subject has an infection/condition that would suppress the immune system, including HIV
  • Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
  • Subject regularly uses illegal drugs
  • Subject consumes more than 3 alcoholic beverages per day
  • Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
  • Subject requires use of any prescription or non-prescription medications during the study
  • Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    MK0822

    Placebo to MK0822

    Outcomes

    Primary Outcome Measures

    Number of Participants With One or More Adverse Events
    Number of Participants Who Discontinued Study Drug Due to Adverse Events

    Secondary Outcome Measures

    Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3

    Full Information

    First Posted
    October 8, 2008
    Last Updated
    February 4, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00770159
    Brief Title
    A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
    Official Title
    A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy Postmenopausal Female Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.

    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
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0822
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to MK0822
    Intervention Type
    Drug
    Intervention Name(s)
    odanacatib
    Intervention Description
    Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo to MK0822
    Intervention Description
    Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.
    Primary Outcome Measure Information:
    Title
    Number of Participants With One or More Adverse Events
    Time Frame
    Up to 7 weeks
    Title
    Number of Participants Who Discontinued Study Drug Due to Adverse Events
    Time Frame
    Up to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3
    Time Frame
    Up to 24 hours postdose, Week 1 and Week 3

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is less than or equal to 75 years of age Subject is a postmenopausal female Subject is within 30% of ideal body weight Subject is judged to be in good health Subject is a nonsmoker Subject is willing to avoid excessive alcohol consumption for the duration of the study Subject is willing to avoid strenuous physical activity for the duration of the study Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study Exclusion Criteria: Subject has a history of multiple/severe allergies to foods or drugs Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases Subject has a history of bone disease or treatment with bisphosphonates Subject has an infection/condition that would suppress the immune system, including HIV Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C Subject regularly uses illegal drugs Subject consumes more than 3 alcoholic beverages per day Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day Subject requires use of any prescription or non-prescription medications during the study Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
    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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    A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

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