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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

odanacatib

Comparator: Placebo

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Odanacatib

Placebo

Outcomes

Primary Outcome Measures

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

Effect of a low-fat meal on pharmacokinetics of MK0822

Secondary Outcome Measures

Full Information

NCT ID

NCT00863525

First Posted

March 16, 2009

Last Updated

August 18, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00863525

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Odanacatib

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

odanacatib

Other Intervention Name(s)

MK0822

Intervention Description

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

Intervention Name(s)

Comparator: Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Throughout the study

Title

Effect of a low-fat meal on pharmacokinetics of MK0822

Time Frame

Through 240 hours post-dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

23013236

Citation

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.

Results Reference

result

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

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