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

Osteoporosis Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863590
• Other study ID #: 0822-001
• Secondary ID: 2009_562
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2009
• Last updated: August 18, 2015
• Start date: June 2004
• Est. completion date: August 2008

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2008
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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
[Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
• Comparator: odanacatib (Panel B)
Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.
• Comparator: odanacatib (Panel C)
Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.
• Comparator: odanacatib (Panel D)
Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability based on assessment of clinical and laboratory adverse experiences		Part I: 12 Weeks, Part II: 13 Weeks	Yes
Secondary	Plasma concentration of MK0822		Up to 336 hours postdose	No