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Trial record 97 of 154 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334787
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: 0.3% OPA-15406 Ointment
Drug: 1% OPA-15406 Ointment
Drug: 3% OPA-15406 Ointment
Drug: Placebo Ointment
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.3% OPA-15406 Ointment 1% OPA-15406 Ointment 3% OPA-15406 Ointment Placebo
Hide Arm/Group Description In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
Period Title: Overall Study
Started 8 8 8 8
Completed 8 8 8 8
Not Completed 0 0 0 0
Arm/Group Title 0.3% OPA-15406 Ointment 1% OPA-15406 Ointment 3% OPA-15406 Ointment Placebo Total
Hide Arm/Group Description In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment. In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
31.9  (7.2) 28.3  (7.6) 30.5  (6.7) 29.5  (6.3) 30.0  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
32
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
8 8 8 8 32
1.Primary Outcome
Title Cmax of OPA-15406 in a Single Administration Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.3% OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administration Period 3% OPA-15406 Ointment in a Single Administration Period
Hide Arm/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.
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.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.508  (0.304) 0.838  (0.531) 1.61  (0.835)
2.Primary Outcome
Title Cmax of OPA-15406 in the Multiple Administration Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3% OPA-15406 Ointment in the Multiple Administration Period
Hide Arm/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.
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.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.506  (0.348) 0.795  (0.208) 1.65  (0.462)
3.Secondary Outcome
Title AUC12h of OPA-15406 in a Single Administration Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.3% OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administration Period 3% OPA-15406 Ointment in a Single Administration Period
Hide Arm/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.
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.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng・h/mL
3.74  (2.32) 6.42  (4.86) 11.2  (6.24)
4.Secondary Outcome
Title AUC12h of OPA-15406 in the Multiple Administration Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3% OPA-15406 Ointment in the Multiple Administration Period
Hide Arm/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.
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.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng・h/mL
4.65  (3.07) 7.84  (1.78) 16.6  (4.99)
Time Frame A single administration: From date of informed consent to 48 hours post dose The multiple administration: From date of assigned IMP twice daily to 16 days post dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.3 % OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administaration Period 3% OPA-15406 Ointment in a Single Administaration Period Placebo in a Single Adminstaration Period 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3 % OPA-15406 Ointment in the Multiple Administration Period Placebo Ointment in the Multiple Administration Period
Hide Arm/Group Description 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment. 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment. 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo 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. 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 placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
All-Cause Mortality
0.3 % OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administaration Period 3% OPA-15406 Ointment in a Single Administaration Period Placebo in a Single Adminstaration Period 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3 % OPA-15406 Ointment in the Multiple Administration Period Placebo Ointment in the Multiple Administration Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.3 % OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administaration Period 3% OPA-15406 Ointment in a Single Administaration Period Placebo in a Single Adminstaration Period 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3 % OPA-15406 Ointment in the Multiple Administration Period Placebo Ointment in the Multiple Administration Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.3 % OPA-15406 Ointment in a Single Administration Period 1% OPA-15406 Ointment in a Single Administaration Period 3% OPA-15406 Ointment in a Single Administaration Period Placebo in a Single Adminstaration Period 0.3 % OPA-15406 Ointment in the Multiple Administration Period 1 % OPA-15406 Ointment in the Multiple Administration Period 3 % OPA-15406 Ointment in the Multiple Administration Period Placebo Ointment in the Multiple Administration Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director, Department of Clinical Management
Organization: Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02334787     History of Changes
Other Study ID Numbers: 271-14-001
First Submitted: January 5, 2015
First Posted: January 8, 2015
Results First Submitted: June 7, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016