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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: odanacatib

• Registration Number: NCT00770159
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-06
• Study Completion: 2005-11
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	odanacatib	MK0822

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Adverse Events	Up to 7 weeks
Number of Participants Who Discontinued Study Drug Due to Adverse Events	Up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3	Up to 24 hours postdose, Week 1 and Week 3