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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770159
• Other study ID #: 0822-005
• Secondary ID: MK0822-0052008_5
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2008
• Last updated: February 4, 2016
• Start date: November 2004
• Est. completion date: November 2005

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Adverse Events		Up to 7 weeks	Yes
Primary	Number of Participants Who Discontinued Study Drug Due to Adverse Events		Up to 6 weeks	Yes
Secondary	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	No