Safety and Tolerability of Odanacatib (0822-059)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01068262
First received: February 11, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib


Condition Intervention Phase
Osteoporosis
Drug: Odanacatib
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Odanacatib (MK0822) in Healthy Male and Postmenopausal Female Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC (0-168 hours) of Odanacatib [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Cmax and C168hr of Odanacatib [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Tmax of Odanacatib [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of Odanacatib administered weekly for 4 consecutive weeks, measured by number of clinical and laboratory adverse experiences [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - Odanacatib
Panel A - Healthy male subjects receiving Odanacatib
Drug: Odanacatib
Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
Other Names:
  • MK0822
  • Odanacatib
Placebo Comparator: Panel A - Placebo
Panel A - Healthy male subjects receiving placebo
Drug: Comparator: Placebo
Oral Placebo tablet administered once weekly for 4 consecutive weeks
Experimental: Panel B - Odanacatib
Panel B - Healthy female subjects receiving Odanacatib
Drug: Odanacatib
Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
Other Names:
  • MK0822
  • Odanacatib
Placebo Comparator: Panel B - Placebo
Panel B - Healthy female subjects receiving placebo
Drug: Comparator: Placebo
Oral Placebo tablet administered once weekly for 4 consecutive weeks

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years
  • Subject is in good general health
  • Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject works night shift and is unable to avoid nightshift work during the study
  • Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks
  • Subject has a history of stroke, chronic seizures, or major neurological disease
  • Subject has a history of cancer
  • Subject consumes excessive amounts of alcohol or caffeine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068262

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01068262     History of Changes
Other Study ID Numbers: 0822-059, 2010_508, MK-0822-059
Study First Received: February 11, 2010
Last Updated: April 22, 2014
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 August 28, 2014