drugset / Trial / NCT03231124

Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

NCT03231124 ↗

Phase 1 Completed 26 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2017-07-25
Primary completion
2017-08-22
Completion
2017-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 32731 Unknown 30 mg Oral

Indications