Healthy Adult Males VolunteersPhase 1NCT05905653
Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
A Phase 1 study testing STN1012600 ophthalmic solution 0.002% in people with Healthy Adult Males Volunteers, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males Volunteers
- What is being tested?
- STN1012600 ophthalmic solution 0.002%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 25 May 2023to 21 Jun 2023
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol
Who cannot join
- Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
- Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.
- Conditions
- Healthy Adult Males Volunteers
- Being tested
- STN1012600 ophthalmic solution 0.002%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN1012600 ophthalmic solution 0.002%Drug
1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| STN1012600 0.002% | Experimental | Not described Receives: Drug: STN1012600 ophthalmic solution 0.002% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
Calculate plasma pharmacokinetic parameters and study pharmacokinetics.
Measured: 1 week, Day 1 and Day 7
Secondary outcomes (1)
Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]
Calculate plasma pharmacokinetic parameters and study pharmacokinetics.
Measured: 1 week, Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start25 May 2023
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Males VolunteersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT05905653
- Sponsor's protocol ID
- 101260007LT
- Status last verified
- Dec 2023
- First submitted
- 25 May 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
- ClinicalTrials.gov ID
- NCT05905653
- Acronym / sponsor ID
- 101260007LT
- Conditions
- Healthy Adult Males Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- 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.
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STN1012600 0.002% | Experimental | Drug: STN1012600 ophthalmic solution 0.002% |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol
Key exclusion criteria (2 listed)
- Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
- Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
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 |
|---|---|---|
| STN1012600 ophthalmic solution 0.002%1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days | Drug | STN1012600 0.002% |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: 1 week, Day 1 and Day 7
Calculate plasma pharmacokinetic parameters and study pharmacokinetics.
1 secondary outcome
Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]
Time frame: 1 week, Day 1 and Day 7
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 5 Dec 2023.
- Individual participant dataSharing planned: No
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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 STN1012600 ophthalmic solution 0.002% in people with Healthy Adult Males Volunteers, 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 5 Dec 2023. 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?
Maximum Plasma Concentration [Cmax] (time frame: 1 week, Day 1 and Day 7). 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 5 Dec 2023.