Overview

Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
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