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

NCT02334787 | Completed Phase 1 Results

• 1 other identifier: 271-14-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14

Secondary Outcomes (2)

• AUC12h of OPA-15406 in a Single Administration Period

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

• AUC12h of OPA-15406 in the Multiple Administration Period

  Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14

Study Arms (8)

0.3% OPA-15406 in a single administration period

EXPERIMENTAL

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

1% OPA-15406 in a single administration period

EXPERIMENTAL

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

3% OPA-15406 in a single administration period

EXPERIMENTAL

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

Placebo in a single administration period

PLACEBO COMPARATOR

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

0.3% OPA-15406 in the multiple administration period

EXPERIMENTAL

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

1% OPA-15406 in the multiple administration period

EXPERIMENTAL

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

3% OPA-15406 in the multiple administration period

EXPERIMENTAL

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

Placebo in the multiple administration period

EXPERIMENTAL

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

Interventions

0.3% OPA-15406 Ointment DRUG

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.

Also known as: OPA-15406 Ointment

0.3% OPA-15406 in a single administration period; 0.3% OPA-15406 in the multiple administration period

1% OPA-15406 Ointment DRUG

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

Also known as: OPA-15406 Ointment

1% OPA-15406 in a single administration period; 1% OPA-15406 in the multiple administration period

3% OPA-15406 Ointment DRUG

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.

Also known as: OPA-15406 Ointment

3% OPA-15406 in a single administration period; 3% OPA-15406 in the multiple administration period

Placebo Ointment DRUG

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.

Placebo in a single administration period; Placebo in the multiple administration period

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director, Department of Clinical Management
• Organization: Otsuka Pharmaceutical Co., LTD.

+81-3-6361-7366

Study Officials

• Hiroaki Ono, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-08

Locations

JP (1)