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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

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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.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: 0.3% OPA-15406 Ointment Drug: 1% OPA-15406 Ointment Drug: 3% OPA-15406 Ointment Drug: Placebo Ointment Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.3% OPA-15406 in a single administration period
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.
Drug: 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 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.
Other Name: OPA-15406 Ointment

Experimental: 1% OPA-15406 in a single administration period
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.
Drug: 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. 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
Other Name: OPA-15406 Ointment

Experimental: 3% OPA-15406 in a single administration period
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.
Drug: 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. 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.
Other Name: OPA-15406 Ointment

Placebo Comparator: Placebo in a single administration period
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.
Drug: Placebo Ointment
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.

Experimental: 0.3% OPA-15406 in the multiple administration period
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.
Drug: 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 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.
Other Name: OPA-15406 Ointment

Experimental: 1% OPA-15406 in the multiple administration period
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.
Drug: 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. 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
Other Name: OPA-15406 Ointment

Experimental: 3% OPA-15406 in the multiple administration period
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.
Drug: 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. 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.
Other Name: OPA-15406 Ointment

Experimental: Placebo in the multiple administration period
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.
Drug: Placebo Ointment
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 Measures :
  1. Cmax of OPA-15406 in a Single Administration Period [ Time Frame: 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.

  2. Cmax of OPA-15406 in the Multiple Administration Period [ Time Frame: 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 :
  1. AUC12h of OPA-15406 in a Single Administration Period [ Time Frame: 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.

  2. AUC12h of OPA-15406 in the Multiple Administration Period [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334787


Locations
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Japan
Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02334787     History of Changes
Other Study ID Numbers: 271-14-001
First Posted: January 8, 2015    Key Record Dates
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases