Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
NCT ID: NCT00769418
Last Updated: 2015-08-19
Study Results
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Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2004-09-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
odanacatib (MK0822)
odanacatib
Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: odanacatib tablets 2.5 mg qd for 14 days.
Panel B: odanacatib tablets 5 mg qd for 14 days.
Panel C: odanacatib tablets 10 mg qd for 14 days.
Panel D: odanacatib tablets 25 mg qd for 14 days.
Panel E: odanacatib tablets 0.5 mg qd for 21 days.
Panel F: odanacatib tablets 2.5 mg qd for 21 days.
Panel G: odanacatib tablets 10 mg qd for 21 days.
2
placebo to odanacatib (MK0822)
Comparator: Placebo
Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.
Panel B: placebo to odanacatib tablets 5 mg qd for 14 days.
Panel C: placebo to odanacatib tablets 10 mg qd for 14 days.
Panel D: placebo to odanacatib tablets 25 mg qd for 14 days.
Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.
Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.
Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.
Interventions
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odanacatib
Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: odanacatib tablets 2.5 mg qd for 14 days.
Panel B: odanacatib tablets 5 mg qd for 14 days.
Panel C: odanacatib tablets 10 mg qd for 14 days.
Panel D: odanacatib tablets 25 mg qd for 14 days.
Panel E: odanacatib tablets 0.5 mg qd for 21 days.
Panel F: odanacatib tablets 2.5 mg qd for 21 days.
Panel G: odanacatib tablets 10 mg qd for 21 days.
Comparator: Placebo
Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.
Panel B: placebo to odanacatib tablets 5 mg qd for 14 days.
Panel C: placebo to odanacatib tablets 10 mg qd for 14 days.
Panel D: placebo to odanacatib tablets 25 mg qd for 14 days.
Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.
Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.
Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be past menopause
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
* Subject is willing to refrain from consuming grapefruit or grapefruit juice
Exclusion Criteria
* Subject has donated blood within 4 weeks of starting the study
* Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
* Subject has any infections or any condition leading to immune problems, including HIV
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject drinks 4 or more caffeinated beverages per day
* Subject uses any prescription or nonprescription medications
18 Years
70 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Other Identifiers
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MK0822-002
Identifier Type: -
Identifier Source: secondary_id
2008_558
Identifier Type: -
Identifier Source: secondary_id
0822-002
Identifier Type: -
Identifier Source: org_study_id
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