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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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.