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

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: odanacatib; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; odanacatib (MK0822)	Drug: odanacatib; Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: odanacatib tablets 2.5 mg qd for 14 days. Panel B: odanacatib tablets 5 mg qd for 14 days. Panel C: odanacatib tablets 10 mg qd for 14 days. Panel D: odanacatib tablets 25 mg qd for 14 days. Panel E: odanacatib tablets 0.5 mg qd for 21 days. Panel F: odanacatib tablets 2.5 mg qd for 21 days. Panel G: odanacatib tablets 10 mg qd for 21 days.; Other Names: MK0822
PLACEBO_COMPARATOR: 2; placebo to odanacatib (MK0822)	Drug: Comparator: Placebo; Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days. Panel B: placebo to odanacatib tablets 5 mg qd for 14 days. Panel C: placebo to odanacatib tablets 10 mg qd for 14 days. Panel D: placebo to odanacatib tablets 25 mg qd for 14 days. Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days. Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days. Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of multiple oral doses of MK0822	After 14 days of treatment for men and 21 days for women

Secondary Outcome Measures

Outcome Measure	Time Frame
PK profile of MK0822	predose and at selected time intervals postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (ACTUAL): December 1, 2004
• Study Completion (ACTUAL): September 1, 2006

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (ESTIMATE): October 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 0822-002; MK0822-002; 2008_558