Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01011725
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Body Composition
Drug: MK0773
Drug: Placebo
Phase 1

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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Serious CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Laboratory Adverse Events (LAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0773
Drug: MK0773
25 mg oral tablet b.i.d. MK0773 or 100 mg oral tablet b.i.d. MK0773, for 12 weeks
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo oral tablet b.i.d for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011725

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT01011725     History of Changes
Other Study ID Numbers: 2009_687, MK0773-003
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014