Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: MK 0773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011725

0773-003

MK0773-003

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Postmenopausal Women- Active Agent Group

Experimental group

Treatment:

Drug: MK 0773

Postmenopausal Women- Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo