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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018282-36 | EudraCT Number |
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The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.
This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E1 | Experimental | ONO-5334 |
|
| E2 | Experimental | ONO-5334 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-5334 | Drug | 150 mg for 5 days administered in the morning or in the evening |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334 | end of treatment (5 days) | |
| Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334 | end of day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women | up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma UK LTD | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guildford Clinical Site | Guildford | Surrey | GU2 7XP | United Kingdom | ||
| London Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26446770 | Derived | Eastell R, Dijk DJ, Small M, Greenwood A, Sharpe J, Yamada H, Yuba M, Tanimoto M, Deacon S. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial. Osteoporos Int. 2016 Jan;27(1):309-18. doi: 10.1007/s00198-015-3342-4. Epub 2015 Oct 7. |
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| ONO-5334 |
| Drug |
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal. |
|
| London |
| SE1 1YR |
| United Kingdom |
| ID | Term |
|---|---|
| C560865 | ONO-5334 |
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