Status:
COMPLETED
A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00770159
Start Date
November 1 2004
End Date
November 1 2005
Last Update
February 5 2016
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