A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
odanacatib
Comparator: placebo to MK0822
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
MK0822
Placebo to MK0822
Outcomes
Primary Outcome Measures
Number of Participants With One or More Adverse Events
Number of Participants Who Discontinued Study Drug Due to Adverse Events
Secondary Outcome Measures
Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3
Full Information
NCT ID
NCT00770159
First Posted
October 8, 2008
Last Updated
February 4, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00770159
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MK0822
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo to MK0822
Intervention Type
Drug
Intervention Name(s)
odanacatib
Intervention Description
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
Intervention Name(s)
Comparator: placebo to MK0822
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Adverse Events
Time Frame
Up to 7 weeks
Title
Number of Participants Who Discontinued Study Drug Due to Adverse Events
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19421185
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.
Results Reference
background
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A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
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