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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: Comparator: placebo to MK0822

Drug: odanacatib

Study type

Interventional

Funder types

Industry

Identifiers

0822-005

2008_559

MK0822-005

Details and patient eligibility

About

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

Enrollment

78 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.