A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00770159
First received: October 8, 2008
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.


Condition Intervention Phase
Osteoporosis
Drug: odanacatib
Drug: Comparator: placebo to MK0822
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy Postmenopausal Female Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • safety and tolerability of once weekly MK0822 [ Time Frame: 3 weeks in Part I, 6 weeks in Part II ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of MK0822 following multiple once-weekly doses [ Time Frame: Predose and at selected time intervals postdose ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: November 2004
Study Completion Date: November 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0822
Drug: odanacatib
Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.
Placebo Comparator: 2
Placebo to MK0822
Drug: Comparator: placebo to MK0822
Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is less than or equal to 75 years of age
  • Subject is a postmenopausal female
  • Subject is within 30% of ideal body weight
  • Subject is judged to be in good health
  • Subject is a nonsmoker
  • Subject is willing to avoid excessive alcohol consumption for the duration of the study
  • Subject is willing to avoid strenuous physical activity for the duration of the study
  • Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study

Exclusion Criteria:

  • Subject has a history of multiple/severe allergies to foods or drugs
  • Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
  • Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
  • Subject has a history of bone disease or treatment with bisphosphonates
  • Subject has an infection/condition that would suppress the immune system, including HIV
  • Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
  • Subject regularly uses illegal drugs
  • Subject consumes more than 3 alcoholic beverages per day
  • Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
  • Subject requires use of any prescription or non-prescription medications during the study
  • Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770159

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00770159     History of Changes
Other Study ID Numbers: 2008_559, MK0822-005
Study First Received: October 8, 2008
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014