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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00863525

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: odanacatib Drug: Comparator: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Randomized, 2-Period Crossover, Placebo Controlled Study to Asses the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MK0822

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Odanacatib	Drug: odanacatib A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods. Other Names: MK0822
Placebo Comparator: 2 Placebo	Drug: Comparator: Placebo A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

Arm

Intervention/Treatment

Experimental: 1

Odanacatib

Drug: odanacatib

A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

Other Names:

MK0822

Placebo Comparator: 2

Placebo

Drug: Comparator: Placebo

A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

Outcome Measures

Primary Outcome Measures

Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences [Throughout the study]
Effect of a low-fat meal on pharmacokinetics of MK0822 [Through 240 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 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 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT00863525

Other Study ID Numbers:

0822-006
2009_563

First Posted:

Mar 18, 2009

Last Update Posted:

Aug 19, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Aug 19, 2015