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

March 16, 2009
March 7, 2014
November 2004
December 2004   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00863525 on ClinicalTrials.gov Archive Site
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A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • 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
  • 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.
  • Experimental: 1
    Odanacatib
    Intervention: Drug: odanacatib
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Comparator: Placebo
Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
June 2006
December 2004   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00863525
0822-006, 2009_563
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP