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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863525

Enrollment

Registered

2009-03-18

Start date

2004-11-30

Completion date

2006-06-30

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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

Interventions

DRUGodanacatib

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.

DRUGComparator: 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026