NCT00769418
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- odanacatib
- Conditions
- Osteoporosis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 62
- Primary Endpoint
- Safety and tolerability of multiple oral doses of MK0822
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
Investigators
Eligibility Criteria
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
Arms & Interventions
1
odanacatib (MK0822)
Intervention: odanacatib
Outcomes
Primary Outcomes
Safety and tolerability of multiple oral doses of MK0822
Time Frame: After 14 days of treatment for men and 21 days for women
Secondary Outcomes
- PK profile of MK0822(predose and at selected time intervals postdose)
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