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

• Sponsor: Merck Sharp & Dohme Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00770159
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: odanacatib; Drug: Comparator: placebo to MK0822	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 MK0822	Drug: odanacatib; Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.
Placebo Comparator: 2 Placebo to MK0822	Drug: Comparator: placebo to MK0822; Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With One or More Adverse Events [Up to 7 weeks]

2. Number of Participants Who Discontinued Study Drug Due to Adverse Events [Up to 6 weeks]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00770159
• Other Study ID Numbers: 0822-005; MK0822-005; 2008_559
• First Posted: Oct 9, 2008
• Last Update Posted: Feb 5, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Osteoporosis

Study Results

No Results Posted as of Feb 5, 2016