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| ID | Type | Description | Link |
|---|---|---|---|
| MK0822-002 | |||
| 2008_558 |
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This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | odanacatib (MK0822) |
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| 2 | Placebo Comparator | placebo to odanacatib (MK0822) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| odanacatib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple oral doses of MK0822 | After 14 days of treatment for men and 21 days for women |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of MK0822 | predose and at selected time intervals postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19421185 | Background | 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. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C527128 | odanacatib |
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| Comparator: Placebo | Drug | 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. |
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| D009750 |
| Nutritional and Metabolic Diseases |