A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)
This study has been completed.
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First received: March 16, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.
|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:
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 ]
|Study Start Date:||November 2004|
|Study Completion Date:||June 2006|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
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
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.
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