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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• BMI = Body weight (kg) / [Height (m)]2: at least 18.5 and less than 25.0

• Judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on Day 1 of the treatment period

Exclusion Criteria:

• Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin

• Judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons