drugset / Trial / NCT02334787

A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects

NCT02334787

Phase 1 Completed 32 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.

Timeline

Start
2015-01
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Difamilast Small molecule 0.3 %
Subject Difamilast Small molecule 1 %
Subject Difamilast Small molecule 3 %

Indications