Osteoporosis
Conditions
Brief summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
Interventions
DRUGMK 0773
25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
DRUGPlacebo
Placebo oral tablet b.i.d for 12 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Serious Clinical Adverse Events | From date of enrollment through 12 weeks of study |
| Number of Participants with Nonerserious Clinical Adverse Events | From date of enrollment through 12 weeks of study |
| Number of Participants with Serious Laboratory Adverse Events | From date of enrollment through 12 weeks of study |
| Number of Participants with Nonserious Laboratory Adverse Events | From date of enrollment through 12 weeks of study |
| Number of Participants Who Discontinued Due to Any Adverse Event | From date of enrollment through 12 weeks of study |
| Number of Participants Who Withdrew Consent and Discontinued the Study | From date of enrollment through 12 weeks of study |
| Least Squares Mean Change in Lean Body Mass | From baseline, at 12 weeks |
Outcome results
None listed