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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo Ointment; Drug: 3% OPA-15406 Ointment; Drug: 0.3% OPA-15406 Ointment; Drug: 1% OPA-15406 Ointment

• Registration Number: NCT02334787
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-06-07
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Results First Posted: 2016-10-03
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo in a single administration period	Placebo Ointment	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.
3% OPA-15406 in a single administration period	3% OPA-15406 Ointment	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.
Placebo in the multiple administration period	Placebo Ointment	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.
0.3% OPA-15406 in a single administration period	0.3% OPA-15406 Ointment	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.
1% OPA-15406 in a single administration period	1% OPA-15406 Ointment	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.
0.3% OPA-15406 in the multiple administration period	0.3% OPA-15406 Ointment	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.
1% OPA-15406 in the multiple administration period	1% OPA-15406 Ointment	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.
3% OPA-15406 in the multiple administration period	3% OPA-15406 Ointment	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.

Primary Outcome Measures

Name	Time	Method
Cmax of OPA-15406 in a Single Administration Period	Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr	We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406.
Cmax of OPA-15406 in the Multiple Administration Period	Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14	We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.

Secondary Outcome Measures

Name	Time	Method
AUC12h of OPA-15406 in a Single Administration Period	Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs	We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406.
AUC12h of OPA-15406 in the Multiple Administration Period	Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14	We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.