A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
Overview
- Phase
- Phase 1
- Intervention
- MK 0773
- Conditions
- Osteoporosis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 67
- Primary Endpoint
- Number of Participants with Serious Clinical Adverse Events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
Investigators
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
Arms & Interventions
Postmenopausal Women- Active Agent Group
Intervention: MK 0773
Postmenopausal Women- Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Serious Clinical Adverse Events
Time Frame: From date of enrollment through 12 weeks of study
Number of Participants with Nonerserious Clinical Adverse Events
Time Frame: From date of enrollment through 12 weeks of study
Number of Participants with Serious Laboratory Adverse Events
Time Frame: From date of enrollment through 12 weeks of study
Number of Participants with Nonserious Laboratory Adverse Events
Time Frame: From date of enrollment through 12 weeks of study
Number of Participants Who Discontinued Due to Any Adverse Event
Time Frame: From date of enrollment through 12 weeks of study
Number of Participants Who Withdrew Consent and Discontinued the Study
Time Frame: From date of enrollment through 12 weeks of study
Least Squares Mean Change in Lean Body Mass
Time Frame: From baseline, at 12 weeks