A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)
- Registration Number
- NCT00863525
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 odanacatib Odanacatib
- Primary Outcome Measures
Name Time Method Effect of a low-fat meal on pharmacokinetics of MK0822 Through 240 hours post-dose Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences Throughout the study
- Secondary Outcome Measures
Name Time Method