Back to resultsA Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
0.3% OPA-15406 Ointment
1% OPA-15406 Ointment
3% OPA-15406 Ointment
Placebo Ointment
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
0.3% OPA-15406 in a single administration period
1% OPA-15406 in a single administration period
3% OPA-15406 in a single administration period
Placebo in a single administration period
0.3% OPA-15406 in the multiple administration period
1% OPA-15406 in the multiple administration period
3% OPA-15406 in the multiple administration period
Placebo in the multiple administration period
Arm 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.
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Cmax of OPA-15406 in a Single Administration Period
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
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
AUC12h of OPA-15406 in a Single Administration Period
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
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.
Full Information
NCT ID
NCT02334787
First Posted
January 5, 2015
Last Updated
August 9, 2016
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02334787
Brief Title
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
Official Title
A Single-center, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Assess the Safety and Pharmacokinetics of OPA-15406 Ointment in Healthy Adult Male Subjects (Phase 1 Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.3% OPA-15406 in a single administration period
Arm Type
Experimental
Arm 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.
Arm Title
1% OPA-15406 in a single administration period
Arm Type
Experimental
Arm 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.
Arm Title
3% OPA-15406 in a single administration period
Arm Type
Experimental
Arm 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.
Arm Title
Placebo in a single administration period
Arm Type
Placebo Comparator
Arm 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.
Arm Title
0.3% OPA-15406 in the multiple administration period
Arm Type
Experimental
Arm 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.
Arm Title
1% OPA-15406 in the multiple administration period
Arm Type
Experimental
Arm 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.
Arm Title
3% OPA-15406 in the multiple administration period
Arm Type
Experimental
Arm 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.
Arm Title
Placebo in the multiple administration period
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
0.3% OPA-15406 Ointment
Other Intervention Name(s)
OPA-15406 Ointment
Intervention Description
32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. 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.
Intervention Type
Drug
Intervention Name(s)
1% OPA-15406 Ointment
Other Intervention Name(s)
OPA-15406 Ointment
Intervention 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. 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
Intervention Type
Drug
Intervention Name(s)
3% OPA-15406 Ointment
Other Intervention Name(s)
OPA-15406 Ointment
Intervention 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. 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.
Intervention Type
Drug
Intervention Name(s)
Placebo Ointment
Intervention Description
32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
Primary Outcome Measure Information:
Title
Cmax of OPA-15406 in a Single Administration Period
Description
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.
Time Frame
Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr
Title
Cmax of OPA-15406 in the Multiple Administration Period
Description
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.
Time Frame
Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
Secondary Outcome Measure Information:
Title
AUC12h of OPA-15406 in a Single Administration Period
Description
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.
Time Frame
Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs
Title
AUC12h of OPA-15406 in the Multiple Administration Period
Description
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.
Time Frame
Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Ono, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Kanto Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
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