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

NCT00769418 | Completed Phase 1

• 3 other identifiers: 0822-002MK0822-0022008_558
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple oral doses of MK0822

  After 14 days of treatment for men and 21 days for women

Secondary Outcomes (1)

• PK profile of MK0822

  predose and at selected time intervals postdose

Study Arms (2)

1

EXPERIMENTAL

odanacatib (MK0822)

Drug: odanacatib

2

PLACEBO COMPARATOR

placebo to odanacatib (MK0822)

Drug: Comparator: Placebo

Interventions

odanacatib DRUG

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.

Also known as: MK0822

1

Comparator: Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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.

  PMID: 19421185 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: September 1, 2006
• Last Updated: August 19, 2015

Record last verified: 2015-08