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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

odanacatib

Drug

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

Comparator: placebo

Drug

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.

Primary outcomes

Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences

Time frame: Throughout the study
Effect of a low-fat meal on pharmacokinetics of MK0822

Time frame: Through 240 hours post-dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2006
First posted: Mar 18, 2009
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed