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

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: MK 0773; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postmenopausal Women- Active Agent Group	Drug: MK 0773; 25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
Placebo Comparator: Postmenopausal Women- Placebo; Placebo	Drug: Placebo; Placebo oral tablet b.i.d for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 0773-003; MK0773-003