Healthy Male AdultsPhase 1NCT02650063
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -
A Phase 1 study testing DE-117 in people with Healthy Male Adults, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Adults
- What is being tested?
- DE-117
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adult volunteers
Who cannot join
- Subjects with any history of severe diseases that preclude participation in this study for safety reasons
- Subjects with any diseases that preclude participation in this study for safety reasons
Trial locations and contacts
1 site in 1 country.
Japan1 site
CPC Clinical Trial Hospital, Medipolis Medical Research Institute
Kagoshima
About this study
The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.
- Conditions
- Healthy Male Adults
- Being tested
- DE-117
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-117Drug
| Study group | Role | What they receive |
|---|---|---|
| DE-117 ophthalmic solution | Experimental | Not described Receives: Drug: DE-117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration-time curve (AUC)
Measured: 7 days
Maximum plasma concentration (Cmax)
Measured: 7 days
Time to maximum plasma concentration (Tmax)
Measured: 7 days
Elimination half-life (T1/2)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male AdultsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650063
- Sponsor's protocol ID
- 01171502
- Status last verified
- Jun 2016
- First submitted
- 4 Jan 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -
- ClinicalTrials.gov ID
- NCT02650063
- Acronym / sponsor ID
- 01171502
- Conditions
- Healthy Male Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DE-117 ophthalmic solution | Experimental | Drug: DE-117 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male adult volunteers
Key exclusion criteria (2 listed)
- Subjects with any history of severe diseases that preclude participation in this study for safety reasons
- Subjects with any diseases that preclude participation in this study for safety 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 |
|---|---|---|
| DE-117 | Drug | DE-117 ophthalmic solution |
Primary outcome
Area under concentration-time curve (AUC)
Time frame: 7 days
Maximum plasma concentration (Cmax)
Time frame: 7 days
Time to maximum plasma concentration (Tmax)
Time frame: 7 days
Elimination half-life (T1/2)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DE-117 in people with Healthy Male Adults, run by Santen 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 1 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 29 Jun 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under concentration-time curve (AUC) (time frame: 7 days). The study lists 4 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 29 Jun 2016.