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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 32731 in healthy male subjects. The trial will be performed in three parts. In Part 1, single doses of LEO 32731 will be administered to healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP0058 oral solution (0.050 mg/mL) | Experimental | LEO 32731 |
|
| LP0058 oral solution (0.200 mg/mL) | Experimental | LEO 32731 |
|
| LP0058 oral solution (placebo) | Placebo Comparator | Placebo |
|
| LP0058 capsule 1-120 mg | Experimental | LEO 32731 |
|
| LP0058 capsule (placebo) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 32731 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate and oral body temperature), ECG, telemetry and clinical laboratory. | 7 days after last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| LEO 32731 and metabolites 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 | United Kingdom |
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