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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000907-26 | EudraCT Number |
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This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects.
Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 32731 | Experimental | Incremental dosing of LEO 32731 progressing to a maximum of 30 mg.
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| Placebo | Placebo Comparator | Incremental dosing of placebo progressing to a maximum of 30 mg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 32731 | Drug | LEO 32731 is being developed by LEO Pharma. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731. | on Day 12 | |
| Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731. | on Day 12 | |
| Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731. | on Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Lorch, MD | Richmond Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | London | SE1 1YR | United Kingdom |
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LEO 32731 and Placebo tablets are of identical appearance. The packaging and labelling of the IMPs and Placebo contain no evidence of their identity. It is not considered possible to differentiate between the IMPs solely by sensory evaluation.
| Placebo |
| Drug |
Placebo contains the same excipients in the same concentration, only lacking LEO 32731 |
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