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

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers

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

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