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| ID | Type | Description | Link |
|---|---|---|---|
| MK0822-005 | |||
| 2008_559 |
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This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0822 |
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| 2 | Placebo Comparator | Placebo to MK0822 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| odanacatib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events | Up to 7 weeks | |
| Number of Participants Who Discontinued Study Drug Due to Adverse Events | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3 | Up to 24 hours postdose, Week 1 and Week 3 |
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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 to MK0822 | Drug | 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. |
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| D009750 |
| Nutritional and Metabolic Diseases |