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

NCT01011725 | Completed Phase 1

• 2 other identifiers: 0773-003MK0773-003
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Postmenopausal Women- Active Agent Group

EXPERIMENTAL

Drug: MK 0773

Postmenopausal Women- Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MK 0773 DRUG

25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks

Postmenopausal Women- Active Agent Group

Placebo DRUG

Placebo oral tablet b.i.d for 12 weeks

Postmenopausal Women- Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

3-fluoro-N-(3H-imidazo(4,5-b)pyridin-2-ylmethyl)-1,4a,6a-trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno(5,4-f)quinoline-7-carboxamide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: March 1, 2009
• Last Updated: August 10, 2016

Record last verified: 2016-02