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

NCT ID: NCT00863590

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-08-31

Brief Summary

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

Conditions

Osteoporosis

Study Design

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

Study Groups

A

Panel A

Group Type: EXPERIMENTAL

odanacatib

Intervention Type: DRUG

\[Intervention Name: odanacatib (Panel A)\] 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.

B

Panel B

Group Type: EXPERIMENTAL

Comparator: odanacatib (Panel B)

Intervention Type: DRUG

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.

C

Panel C

Group Type: EXPERIMENTAL

Comparator: odanacatib (Panel C)

Intervention Type: DRUG

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.

D

Panel D

Group Type: EXPERIMENTAL

Comparator: odanacatib (Panel D)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• 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_562

Identifier Type: -

Identifier Source: secondary_id

0822-001

Identifier Type: -

Identifier Source: org_study_id