A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: odanacatib; Drug: Comparator: odanacatib (Panel D); Drug: Comparator: odanacatib (Panel B); Drug: Comparator: odanacatib (Panel C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863590

0822-001

2009_562

Details and patient eligibility

About

This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is in good health
• Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
• Female subject is postmenopausal
• Subject is within 20% of ideal body weight
• 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 consumes excessive amounts of caffeine or alcohol
• Subject has donated blood or taken another investigational drug in the last month
• 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: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

A

Experimental group

Description:

Panel A

Treatment:

Drug: odanacatib

B

Experimental group

Description:

Panel B

Treatment:

Drug: Comparator: odanacatib (Panel B)

C

Experimental group

Description:

Panel C

Treatment:

Drug: Comparator: odanacatib (Panel C)

D

Experimental group

Description:

Panel D

Treatment:

Drug: Comparator: odanacatib (Panel D)