Back to resultsSafety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK 0773
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Subject is a nonsurgical postmenopausal female
- Subject is neither grossly overweight nor underweight for her height
- Subject is in good health
- Subject is willing to avoid excess alcohol and strenuous physical activity during the study
- Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study
Exclusion Criteria:
- Subject has significant drug allergies
- Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
- Subject is a regular user or past abuser of any illicit drug (including alcohol)
- Subject drinks excessive amounts of caffeinated beverages
- Subject has a history of cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Postmenopausal Women- Active Agent Group
Postmenopausal Women- Placebo
Arm Description
Placebo
Outcomes
Primary Outcome Measures
Number of Participants with Serious Clinical Adverse Events
Number of Participants with Nonerserious Clinical Adverse Events
Number of Participants with Serious Laboratory Adverse Events
Number of Participants with Nonserious Laboratory Adverse Events
Number of Participants Who Discontinued Due to Any Adverse Event
Number of Participants Who Withdrew Consent and Discontinued the Study
Least Squares Mean Change in Lean Body Mass
Secondary Outcome Measures
Full Information
NCT ID
NCT01011725
First Posted
November 10, 2009
Last Updated
August 9, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01011725
Brief Title
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
March 2009 (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, pharmacokinetics, and pharmacodynamic efficacy of MK0773 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
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postmenopausal Women- Active Agent Group
Arm Type
Experimental
Arm Title
Postmenopausal Women- Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MK 0773
Intervention Description
25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablet b.i.d for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants with Serious Clinical Adverse Events
Time Frame
From date of enrollment through 12 weeks of study
Title
Number of Participants with Nonerserious Clinical Adverse Events
Time Frame
From date of enrollment through 12 weeks of study
Title
Number of Participants with Serious Laboratory Adverse Events
Time Frame
From date of enrollment through 12 weeks of study
Title
Number of Participants with Nonserious Laboratory Adverse Events
Time Frame
From date of enrollment through 12 weeks of study
Title
Number of Participants Who Discontinued Due to Any Adverse Event
Time Frame
From date of enrollment through 12 weeks of study
Title
Number of Participants Who Withdrew Consent and Discontinued the Study
Time Frame
From date of enrollment through 12 weeks of study
Title
Least Squares Mean Change in Lean Body Mass
Time Frame
From baseline, at 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is a nonsurgical postmenopausal female
Subject is neither grossly overweight nor underweight for her height
Subject is in good health
Subject is willing to avoid excess alcohol and strenuous physical activity during the study
Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study
Exclusion Criteria:
Subject has significant drug allergies
Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
Subject is a regular user or past abuser of any illicit drug (including alcohol)
Subject drinks excessive amounts of caffeinated beverages
Subject has a history of cancer
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
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
We'll reach out to this number within 24 hrs