GlaucomaPhase 1NCT02967614
KJ-TFC-004 Drug-drug Interaction Study
A Phase 1 study testing [A], [B] and [A]+[B](1) in people with Glaucoma and Eye Diseases, run by Kukje Pharma at 1 site in South Korea.
Trial summary
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Eye Diseases, Ocular Hypertension
- What is being tested?
- [A], [B] and [A]+[B](1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to 1 Apr 2018
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged between 19 and 50 during screening period
- BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
- Signed the informed consent form prior to study participation.
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.
Read the detailed description
Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers
- Conditions
- Glaucoma, Eye Diseases, Ocular Hypertension
- Being tested
- [A], [B], [A]+[B](1), [A]+[B](2)
- Medical subject headings
- Glaucoma, Eye Diseases, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[A]Drug
Also called Brimonidine , Timolol
One eye drop(about 40ul) / Day1 ~ Day8 / BID
[B]Drug
Also called Dorzolamide
One eye drop(about 40ul) / Day1 ~ Day92 / BID
[A]+[B](1)Drug
Also called Brimonidine , Timolol , Dorzolamide
One eye drop(about 40ul) / Day9 ~ Day100 / BID
[A]+[B](2)Drug
Also called Brimonidine , Timolol , Dorzolamide
One eye drop(about 40ul) / Day93 ~ Day100 / BID
| Study group | Role | What they receive |
|---|---|---|
| [A]→[A]+[B] | Experimental | Period 1 : At each dosing of Treatment A eye drops is administered for 8days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days Receives: Drug: [A]; Drug: [A]+[B](1) |
| [B]→[A]+[B] | Experimental | Period 1 : At each dosing of Treatment B eye drops is administered for 92days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days Receives: Drug: [B]; Drug: [A]+[B](2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Brimonidine and Dorzolamide
Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point)
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)
Dorzolamide
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point)
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)
Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)
Measured: pre- and post dose of Brimonidine and Dorzolamide administration]
Secondary outcomes (1)
Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h 8d 0h (pre-dose),8d 0.25,0.5,0.75,1,1.5,2,2.5,3, 4,8,12 h post-dose (Total 15Point)
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Dorzolamide
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
Dorzolamide Period 1 : 1d 0h,15d 0h,29d 0h,43d 0h,57d 0h,71d 0h,85d 0h,91d 0h, 91d 12h,92d 0h(pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Period 1 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
Measured: pre- and post dose of Dorzolamide and Dorzloamide administration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kukje Pharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyung-sang Yu, Ph.d., M.B.A, Principal investigator, Clinical Trial Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967614
- Sponsor's protocol ID
- KJ-TFC-004
- Status last verified
- Nov 2016
- First submitted
- 12 Nov 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers
- ClinicalTrials.gov ID
- NCT02967614
- Acronym / sponsor ID
- KJ-TFC-004
- Conditions
- Glaucoma, Eye Diseases, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kukje PharmaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 18 Nov 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.
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.
Detailed description
Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [A]→[A]+[B] | Experimental | Drug: [A], Drug: [A]+[B](1)Period 1 : At each dosing of Treatment A eye drops is administered for 8days Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days |
| [B]→[A]+[B] | Experimental | Drug: [B], Drug: [A]+[B](2)Period 1 : At each dosing of Treatment B eye drops is administered for 92days Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male adults aged between 19 and 50 during screening period
- BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
- Signed the informed consent form prior to study participation.
Key exclusion criteria (1 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
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 |
|---|---|---|
| [A]Also: Brimonidine , TimololOne eye drop(about 40ul) / Day1 ~ Day8 / BID | Drug | [A]→[A]+[B] |
| [B]Also: DorzolamideOne eye drop(about 40ul) / Day1 ~ Day92 / BID | Drug | [B]→[A]+[B] |
| [A]+[B](1)Also: Brimonidine , Timolol , DorzolamideOne eye drop(about 40ul) / Day9 ~ Day100 / BID | Drug | [A]→[A]+[B] |
| [A]+[B](2)Also: Brimonidine , Timolol , DorzolamideOne eye drop(about 40ul) / Day93 ~ Day100 / BID | Drug | [B]→[A]+[B] |
Primary outcome
Plasma concentration of Brimonidine and Dorzolamide
Time frame: pre- and post dose of Brimonidine and Dorzolamide administration]
Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point) Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Dorzolamide Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point) Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point) Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point) Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)
1 secondary outcome
Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
Time frame: pre- and post dose of Dorzolamide and Dorzloamide administration]
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 11 Apr 2018.
- 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.
Kyung-sang Yu, Ph.d., M.B.A principal investigator
Clinical Trial Center, Seoul National University Hospital
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 [A], [B] and [A]+[B](1) in people with Glaucoma and Eye Diseases, run by Kukje Pharma at 1 site in South Korea.
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 3 inclusion and 1 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 11 Apr 2018. 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 South Korea. 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?
Plasma concentration of Brimonidine and Dorzolamide (time frame: pre- and post dose of Brimonidine and Dorzolamide administration]). 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 11 Apr 2018.