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

Merck Sharp & Dohme LLC0 sites78 target enrollmentNovember 2004

Interventionsodanacatib

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

November 2005

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Responsible Party

Sponsor

•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

•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