Clinical trial NCT00770159: A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With One or More Adverse Events
timeFrame: Up to 7 weeks
measure: Number of Participants Who Discontinued Study Drug Due to Adverse Events
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3
timeFrame: Up to 24 hours postdose, Week 1 and Week 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.