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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: 1% OPA-15406 Ointment; Drug: Placebo Ointment; Drug: 0.3% OPA-15406 Ointment; Drug: 3% OPA-15406 Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02334787

271-14-001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 8 patient groups, including a placebo group

0.3% OPA-15406 in a single administration period

Experimental group

Description:

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3% OPA-15406 ointment assessed until 48 hours postdose.

Treatment:

Drug: 0.3% OPA-15406 Ointment

1% OPA-15406 in a single administration period

Experimental group

Description:

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.

Treatment:

Drug: 1% OPA-15406 Ointment

3% OPA-15406 in a single administration period

Experimental group

Description:

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.

Treatment:

Drug: 3% OPA-15406 Ointment

Placebo in a single administration period

Placebo Comparator group

Description:

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned placebo ointment assessed until 48 hours postdose.

Treatment:

Drug: Placebo Ointment

0.3% OPA-15406 in the multiple administration period

Experimental group

Description:

In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

Treatment:

Drug: 0.3% OPA-15406 Ointment

1% OPA-15406 in the multiple administration period

Experimental group

Description:

In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

Treatment:

Drug: 1% OPA-15406 Ointment

3% OPA-15406 in the multiple administration period

Experimental group

Description:

In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

Treatment:

Drug: 3% OPA-15406 Ointment

Placebo in the multiple administration period

Experimental group

Description:

In the multiple administration period, same subjects were treated with assigned OPA-15406 ointment placebo twice daily for 14 days and assessed until 48 hours post dose.

Treatment:

Drug: Placebo Ointment