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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: odanacatib; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863525

0822-006

2009_563

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Odanacatib

Treatment:

Drug: odanacatib

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo