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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769418
• Other study ID #: 0822-002
• Secondary ID: MK0822-0022008_5
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2008
• Last updated: August 18, 2015
• Start date: September 2004
• Est. completion date: September 2006

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of multiple oral doses of MK0822		After 14 days of treatment for men and 21 days for women	Yes
Secondary	PK profile of MK0822		predose and at selected time intervals postdose	No