A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.

Official Title
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A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy Postmenopausal Female Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: odanacatib
* Drug: Comparator: placebo to MK0822


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is less than or equal to 75 years of age Subject is a postmenopausal female Subject is within 30% of ideal body weight Subject is judged to be in good health Subject is a nonsmoker Subject is willing to avoid excessive alcohol consumption for the duration of the study Subject is willing to avoid strenuous physical activity for the duration of the study Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study Exclusion Criteria: Subject has a history of multiple/severe allergies to foods or drugs Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases Subject has a history of bone disease or treatment with bisphosphonates Subject has an infection/condition that would suppress the immune system, including HIV Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C Subject regularly uses illegal drugs Subject consumes more than 3 alcoholic beverages per day Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day Subject requires use of any prescription or non-prescription medications during the study Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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>MK0822 | Drug: odanacatib<br>* Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.<br>|
| Placebo Comparator: 2<br>Placebo to MK0822 | Drug: Comparator: placebo to MK0822<br>* Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Adverse Events |  | Up to 7 weeks | 
| Number of Participants Who Discontinued Study Drug Due to Adverse Events |  | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3 |  | Up to 24 hours postdose, Week 1 and Week 3 |