Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Osteoporosis

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00863590

Start Date

June 1 2004

End Date

August 1 2008

Last Update

August 19 2015

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