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The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 27847 in healthy male subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 27847 will be administered to healthy male subjects. In Part 2, multiple doses of LEO 27847 will be administered to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 27847 oral solution (0.05 mg/mL) | Experimental | LEO 27847 |
|
| LEO 27847 oral solution (0.75 mg/mL) | Experimental | LEO 27847 |
|
| LEO 27847 oral solution (placebo) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 27847 | Drug | First in man |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 7 days after last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| LEO 27847 in blood and urine | 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Chiesa, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. | Leeds | LS2 9LH | United Kingdom |
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