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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_562 |
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This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Panel A |
|
| B | Experimental | Panel B |
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| C | Experimental | Panel C |
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| D | Experimental | Panel D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| odanacatib | Drug | [Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability based on assessment of clinical and laboratory adverse experiences | Part I: 12 Weeks, Part II: 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of MK0822 | Up to 336 hours 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 |
|---|---|---|---|
| 23013236 | Result | Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x. |
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| Comparator: odanacatib (Panel B) | Drug | Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period. |
|
| Comparator: odanacatib (Panel C) | Drug | Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period. |
|
| Comparator: odanacatib (Panel D) | Drug | Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C527128 | odanacatib |
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