A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Subject is in good health

• Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger

• Female subject is postmenopausal

• Subject is within 20% of ideal body weight

• 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 consumes excessive amounts of caffeine or alcohol

• Subject has donated blood or taken another investigational drug in the last month

• Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug