Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: odanacatib
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age Females must be past menopause Subject is a nonsmoker Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling Subject is willing to refrain from consuming grapefruit or grapefruit juice Exclusion Criteria: Subject has a history of multiple/severe allergies to drugs or food Subject has donated blood within 4 weeks of starting the study Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment Subject has any infections or any condition leading to immune problems, including HIV Subject regularly uses illegal drugs Subject consumes more than 3 alcoholic beverages per day Subject drinks 4 or more caffeinated beverages per day Subject uses any prescription or nonprescription medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>odanacatib (MK0822) | Drug: odanacatib<br>* Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: odanacatib tablets 2.5 mg qd for 14 days. Panel B: odanacatib tablets 5 mg qd for 14 days. Panel C: odanacatib tablets 10 mg qd for 14 days. Panel D: odanacatib tablets 25 mg qd for 14 days. Panel E: odanacatib tablets 0.5 mg qd for 21 days. Panel F: odanacatib tablets 2.5 mg qd for 21 days. Panel G: odanacatib tablets 10 mg qd for 21 days.<br>* Other names: MK0822;|
| Placebo Comparator: 2<br>placebo to odanacatib (MK0822) | Drug: Comparator: Placebo<br>* Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only. Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days. Panel B: placebo to odanacatib tablets 5 mg qd for 14 days. Panel C: placebo to odanacatib tablets 10 mg qd for 14 days. Panel D: placebo to odanacatib tablets 25 mg qd for 14 days. Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days. Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days. Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of multiple oral doses of MK0822 |  | After 14 days of treatment for men and 21 days for women | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of MK0822 |  | predose and at selected time intervals postdose |