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A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00863525
First received: March 16, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, 2-Period Crossover, Placebo Controlled Study to Asses the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MK0822

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Effect of a low-fat meal on pharmacokinetics of MK0822 [ Time Frame: Through 240 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: November 2004
Study Completion Date: June 2006
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Odanacatib
Drug: odanacatib
A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
Other Name: MK0822
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is male and between the ages of 18 and 45
  • Subject is within 25% of ideal body weight and weighs between 55 and 95 kg
  • Subject is in generally good health
  • Subject is a nonsmoker

Exclusion Criteria:

  • Subject has multiple or severe allergies to food or medications
  • Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
  • Subject has any infections, including HIV
  • Subject has donated blood or taken another investigational drug in the last month
  • Subject consumes excessive amounts of caffeine or alcohol
  • Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
  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: NCT00863525

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: NCT00863525     History of Changes
Other Study ID Numbers: 0822-006, 2009_563
Study First Received: March 16, 2009
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014