Status:

COMPLETED

A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Osteoporosis

Eligibility:

MALE

18-45 years

Phase:

PHASE1

Brief Summary

This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.

Eligibility Criteria

Inclusion

  • Subject is male and between the ages of 18 and 45
  • Subject is within 25% of ideal body weight and weighs between 55 and 95 kg
  • Subject is in generally good health
  • 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 has donated blood or taken another investigational drug in the last month
  • Subject consumes excessive amounts of caffeine or alcohol
  • 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 :

November 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2006

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT00863525

Start Date

November 1 2004

End Date

June 1 2006

Last Update

August 19 2015

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