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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011725
• Other study ID #: 0773-003
• Secondary ID: MK0773-003
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: August 9, 2016
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2009
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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
Placebo oral tablet b.i.d for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious Clinical Adverse Events		From date of enrollment through 12 weeks of study	Yes
Primary	Number of Participants with Nonerserious Clinical Adverse Events		From date of enrollment through 12 weeks of study	Yes
Primary	Number of Participants with Serious Laboratory Adverse Events		From date of enrollment through 12 weeks of study	Yes
Primary	Number of Participants with Nonserious Laboratory Adverse Events		From date of enrollment through 12 weeks of study	Yes
Primary	Number of Participants Who Discontinued Due to Any Adverse Event		From date of enrollment through 12 weeks of study	Yes
Primary	Number of Participants Who Withdrew Consent and Discontinued the Study		From date of enrollment through 12 weeks of study	Yes
Primary	Least Squares Mean Change in Lean Body Mass		From baseline, at 12 weeks	No