Overview
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
Status:
Completed
Completed
Trial end date:
2006-09-01
2006-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Merck Sharp & Dohme Corp.
Criteria
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