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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: odanacatib

• Registration Number: NCT00863590
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-02
• Study Completion: 2008-08
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-18
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	odanacatib	Panel A

Primary Outcome Measures

Name	Time	Method
safety and tolerability based on assessment of clinical and laboratory adverse experiences	Part I: 12 Weeks, Part II: 13 Weeks

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of MK0822	Up to 336 hours postdose