Phase 1 Completed N=32 Randomized Double-blind Treatment

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

Atopic Dermatitis

Source: ClinicalTrials.gov NCT02334787 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcomePrimary: Cmax of OPA-15406 in a Single Administration Period — 0.508; 0.838; 1.61 ng/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax of OPA-15406 in a Single Administration Period	0.508; 0.838; 1.61	—
PRIMARY Cmax of OPA-15406 in the Multiple Administration Period	0.506; 0.795; 1.65	—
SECONDARY AUC12h of OPA-15406 in a Single Administration Period	3.74; 6.42; 11.2	—
SECONDARY AUC12h of OPA-15406 in the Multiple Administration Period	4.65; 7.84; 16.6	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT02334787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.