Status:
COMPLETED
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00769418
Start Date
September 1 2004
End Date
September 1 2006
Last Update
August 19 2015
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