Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
- Registration Number
- NCT00769418
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
- Females must be past menopause
- Subject is a nonsmoker
- Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
- Subject is willing to refrain from consuming grapefruit or grapefruit juice
Exclusion Criteria
- Subject has a history of multiple/severe allergies to drugs or food
- Subject has donated blood within 4 weeks of starting the study
- Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
- Subject has any infections or any condition leading to immune problems, including HIV
- Subject regularly uses illegal drugs
- Subject consumes more than 3 alcoholic beverages per day
- Subject drinks 4 or more caffeinated beverages per day
- Subject uses any prescription or nonprescription medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 odanacatib odanacatib (MK0822)
- Primary Outcome Measures
Name Time Method Safety and tolerability of multiple oral doses of MK0822 After 14 days of treatment for men and 21 days for women
- Secondary Outcome Measures
Name Time Method PK profile of MK0822 predose and at selected time intervals postdose