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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:
ClinicalTrials.gov Identifier:
NCT00863525
First Posted: March 18, 2009
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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

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 ]
  • Effect of a low-fat meal on pharmacokinetics of MK0822 [ Time Frame: Through 240 hours post-dose ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 16, 2009
First Posted: March 18, 2009
Last Update Posted: August 19, 2015
Last Verified: August 2015

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