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

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

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: odanacatib
* Drug: Comparator: odanacatib (Panel B)
* Drug: Comparator: odanacatib (Panel C)
* Drug: Comparator: odanacatib (Panel D)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Panel A | Drug: odanacatib<br>* [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.<br>|
| Experimental: B<br>Panel B | Drug: Comparator: odanacatib (Panel B)<br>* 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.<br>|
| Experimental: C<br>Panel C | Drug: Comparator: odanacatib (Panel C)<br>* 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.<br>|
| Experimental: D<br>Panel D | Drug: Comparator: odanacatib (Panel D)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability based on assessment of clinical and laboratory adverse experiences |  | Part I: 12 Weeks, Part II: 13 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of MK0822 |  | Up to 336 hours postdose |