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

NCT00863525 | Completed Phase 1

• 2 other identifiers: 0822-0062009_563
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences

  Throughout the study

• Effect of a low-fat meal on pharmacokinetics of MK0822

  Through 240 hours post-dose

Study Arms (2)

1

EXPERIMENTAL

Odanacatib

Drug: odanacatib

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

odanacatib 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.

Also known as: MK0822

1

Comparator: Placebo 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.

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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, 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.

  PMID: 23013236 RESULT

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: November 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: June 1, 2006
• Last Updated: August 19, 2015

Record last verified: 2015-08