Atopic DermatitisPhase 1NCT02334787
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
A Phase 1 study testing 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment and 3% OPA-15406 Ointment in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment and 3% OPA-15406 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment, 3% OPA-15406 Ointment, Placebo Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% OPA-15406 OintmentDrug
Also called 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.
1% OPA-15406 OintmentDrug
Also called 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
3% OPA-15406 OintmentDrug
Also called 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.
Placebo OintmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs
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.
Measured: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroaki Ono, Mr, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334787
- Sponsor's protocol ID
- 271-14-001
- Status last verified
- Aug 2016
- First submitted
- 5 Jan 2015
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02334787
- Acronym / sponsor ID
- 271-14-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 0.3% OPA-15406 in a single administration period | Experimental | Drug: 0.3% OPA-15406 Ointment32 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 in a single administration period | Experimental | Drug: 1% OPA-15406 Ointment32 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 in a single administration period | Experimental | Drug: 3% OPA-15406 Ointment32 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. |
| Placebo in a single administration period | Placebo comparator | Drug: Placebo Ointment32 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. |
| 0.3% OPA-15406 in the multiple administration period | Experimental | Drug: 0.3% OPA-15406 OintmentIn 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. |
| 1% OPA-15406 in the multiple administration period | Experimental | Drug: 1% OPA-15406 OintmentIn 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. |
| 3% OPA-15406 in the multiple administration period | Experimental | Drug: 3% OPA-15406 OintmentIn 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. |
| Placebo in the multiple administration period | Experimental | Drug: Placebo OintmentIn 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3% OPA-15406 OintmentAlso: OPA-15406 Ointment32 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. | Drug | 0.3% OPA-15406 in a single administration period, 0.3% OPA-15406 in the multiple administration period |
| 1% OPA-15406 OintmentAlso: OPA-15406 Ointment32 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 | Drug | 1% OPA-15406 in a single administration period, 1% OPA-15406 in the multiple administration period |
| 3% OPA-15406 OintmentAlso: OPA-15406 Ointment32 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. | Drug | 3% OPA-15406 in a single administration period, 3% OPA-15406 in the multiple administration period |
| Placebo Ointment32 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. | Drug | Placebo in a single administration period, Placebo in the multiple administration period |
Primary outcome
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.
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.
2 secondary outcomes
AUC12h of OPA-15406 in a Single Administration Period
Time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroaki Ono, Mr study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment and 3% OPA-15406 Ointment in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of OPA-15406 in a Single Administration Period (time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.