A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)

Osteoporosis Clinical Trial

Official title:

A Double-Blind, Randomized, 2-Period Crossover, Placebo Controlled Study to Asses the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MK0822

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863525
• Other study ID #: 0822-006
• Secondary ID: 2009_563
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2009
• Last updated: August 18, 2015
• Start date: November 2004
• Est. completion date: June 2006

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subject is male and between the ages of 18 and 45

• Subject is within 25% of ideal body weight and weighs between 55 and 95 kg

• Subject is in generally good health

• 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 has donated blood or taken another investigational drug in the last month

• Subject consumes excessive amounts of caffeine or alcohol

• 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: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• odanacatib
A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
• Comparator: Placebo
A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.

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 of MK0822 based on clinical and laboratory adverse experiences		Throughout the study	Yes
Primary	Effect of a low-fat meal on pharmacokinetics of MK0822		Through 240 hours post-dose	No