Trial Outcomes & Findings for A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects (NCT NCT02334787)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr

Results posted on

2016-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	0.3% OPA-15406 Ointment In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.	1% OPA-15406 Ointment In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.	3% OPA-15406 Ointment In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.	Placebo In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
Overall Study STARTED	8	8	8	8
Overall Study COMPLETED	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.3% OPA-15406 Ointment n=8 Participants In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.	1% OPA-15406 Ointment n=8 Participants In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.	3% OPA-15406 Ointment n=8 Participants In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.	Placebo n=8 Participants In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants	8 Participants n=107 Participants	8 Participants n=206 Participants	8 Participants n=7 Participants	32 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Continuous	31.9 years STANDARD_DEVIATION 7.2 • n=99 Participants	28.3 years STANDARD_DEVIATION 7.6 • n=107 Participants	30.5 years STANDARD_DEVIATION 6.7 • n=206 Participants	29.5 years STANDARD_DEVIATION 6.3 • n=7 Participants	30.0 years STANDARD_DEVIATION 6.8 • n=31 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	8 Participants n=107 Participants	8 Participants n=206 Participants	8 Participants n=7 Participants	32 Participants n=31 Participants
Region of Enrollment Japan	8 participants n=99 Participants	8 participants n=107 Participants	8 participants n=206 Participants	8 participants n=7 Participants	32 participants n=31 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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 Ointment in a Single Administration Period n=8 Participants 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.	3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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.
Cmax of OPA-15406 in a Single Administration Period	0.508 ng/mL Standard Deviation 0.304	0.838 ng/mL Standard Deviation 0.531	1.61 ng/mL Standard Deviation 0.835

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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 Ointment in a Single Administration Period n=8 Participants 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.	3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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.
Cmax of OPA-15406 in the Multiple Administration Period	0.506 ng/mL Standard Deviation 0.348	0.795 ng/mL Standard Deviation 0.208	1.65 ng/mL Standard Deviation 0.462

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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 Ointment in a Single Administration Period n=8 Participants 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.	3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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.
AUC12h of OPA-15406 in a Single Administration Period	3.74 ng･h/mL Standard Deviation 2.32	6.42 ng･h/mL Standard Deviation 4.86	11.2 ng･h/mL Standard Deviation 6.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0.3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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 Ointment in a Single Administration Period n=8 Participants 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.	3% OPA-15406 Ointment in a Single Administration Period n=8 Participants 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.
AUC12h of OPA-15406 in the Multiple Administration Period	4.65 ng･h/mL Standard Deviation 3.07	7.84 ng･h/mL Standard Deviation 1.78	16.6 ng･h/mL Standard Deviation 4.99

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director, Department of Clinical Management

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place