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

NCT ID: NCT00863525

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-06-30

Brief Summary

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

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Odanacatib

Group Type: EXPERIMENTAL

odanacatib

Intervention Type: DRUG

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.

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

MK0822

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.

Reference Type: RESULT

PMID: 23013236 (View on PubMed)

Other Identifiers

2009_563

Identifier Type: -

Identifier Source: secondary_id

0822-006

Identifier Type: -

Identifier Source: org_study_id