Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

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

NCT00769418

MK0822-002

0822-002

2008_558

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).

Enrollment

62 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
Females must be past menopause
Subject is a nonsmoker
Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion criteria

Subject has a history of multiple/severe allergies to drugs or food
Subject has donated blood within 4 weeks of starting the study
Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
Subject has any infections or any condition leading to immune problems, including HIV
Subject regularly uses illegal drugs
Subject consumes more than 3 alcoholic beverages per day
Subject drinks 4 or more caffeinated beverages per day
Subject uses any prescription or nonprescription medications