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

NCT ID: NCT00770159

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-11-30

Brief Summary

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

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

MK0822

Group Type: EXPERIMENTAL

odanacatib

Intervention Type: DRUG

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.

2

Placebo to MK0822

Group Type: PLACEBO_COMPARATOR

Comparator: placebo to MK0822

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 19421185 (View on PubMed)

Other Identifiers

MK0822-005

Identifier Type: -

Identifier Source: secondary_id

2008_559

Identifier Type: -

Identifier Source: secondary_id

0822-005

Identifier Type: -

Identifier Source: org_study_id