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Safety and Tolerability of Odanacatib (0822-059)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01068262
First received: February 11, 2010
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01068262     History of Changes
Other Study ID Numbers: 2010_508, MK0822-059
Study First Received: February 11, 2010
Last Updated: January 5, 2012
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 May 16, 2013