A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
February 4, 2016 updated by: Merck Sharp & Dohme LLC
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
This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
MK0822
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants With One or More Adverse Events
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
|
Number of Participants Who Discontinued Study Drug Due to Adverse Events
Time Frame: Up to 6 weeks
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3
Time Frame: Up to 24 hours postdose, Week 1 and Week 3
|
Up to 24 hours postdose, Week 1 and Week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
October 8, 2008
First Submitted That Met QC Criteria
October 8, 2008
First Posted (Estimate)
October 9, 2008
Study Record Updates
Last Update Posted (Estimate)
February 5, 2016
Last Update Submitted That Met QC Criteria
February 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0822-005
- MK0822-005
- 2008_559
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.