GlaucomaPhase 1NCT05207761
Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930
A Phase 1 study testing D565 and D930 in people with Glaucoma, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- D565 and D930
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jan 2022to 2 Nov 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults volunteers aged between 19 and 55 years old at the time of screening
- Weight ≥ 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
- Individuals who are suitable as a subject for this study at the discretion of the researcher as a result of screening tests such as examination, laboratory tests and questionnaires
Who cannot join
- Individuals who have other clinically significant cardiovascular system, respiratory system, liver, renal, nervous system, endocrine system, blood-oncology, psychiatric disorders, urinary system or ophthalmic diseases or have a history
- Individuals who satisfy the following items during the interview or examination
- Individuals with a history of or sign or symptoms of a disease of the visual system
- Individuals who had an ophthalmic surgery including for refractive correction surgery such as LASIK.
- Individuals with corrected visual acuity of 20/40 or less
- Individuals who have experienced side effects after wearing contact lenses or who have worn contact lenses within the last month
Show all 26Show fewer
- Individuals who have more than 21mmHg or less than 10mmHg on either side of the intraocular pressure test
- Individuals who show abnormal findings in other ophthalmic examinations
- Individuals who have a history of hypersensitivity to the active ingredient and component of the investigational drug, or to the drug in the same class as the active ingredient
- Individuals with sitting systolic blood pressure ≥ 140 mmHg or ≤ 80 mmHg or sitting diastolic blood pressure ≥ 90 mmHg or ≤ 45 mmHg
- Individuals with the following results at screening test
- AST, ALT, γ-GT > 2x the upper limit of the normal range
- Total bilirubin > 2.0 mg/dL
- eGFR(CKD-EPI) < 60 mL/min/1.73m2
- Individuals who continue to drink(over 21 units/week) within 1 month or cannot abstain from alcohol during the clinical trial period
- Individuals who tested positive in an alcohol breath analysis
- Individuals who continuously smoke within one month(including e-cigarettes, over 10 fees/day) or who cannot quit smoking during the clinical trial period;
- Individuals who cannot restrict the intake of grapefruit or grapefruit-containing food from 3 days before administration of investigational drugs to the final pharmacokinetic blood sample collection
- Individuals who tested positive for urine cotinine at screening test
- Individuals who took ethical(ETC) or oriental medicine within 2 weeks or over the counter(OTC) within 1 week before the expected first dose
- Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the expected first dose
- Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
- Individuals who had been administered investigational product(s) of other clinical study within the 6 months prior to the first dose of this study
- Individuals who donated whole blood within the 2 months, or donated blood components within 1 month, or received a blood transfusion with 1month prior to the first dose or plan to donate blood or transfusion during the clinical trial period
- Individuals who are unable to use an appropriate medically approved method of contraception for themselves, their spouses, or partners during the entire clinical trial period and for at least 90 days after the last investigational drug administration and cannot donate sperm during this period
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University College of Medicine and Hospital
Seoul
About this study
Official title: A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930, in Healthy Male Subjects
This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects
Read the detailed description
To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period
- Conditions
- Glaucoma
- Being tested
- D565, D930
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D565Drug
Q.D. in both eye
D930Drug
T.I.D in both eye
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 1. Period 1: D565 7days
2. Period 2: D565+D930 91days Receives: Drug: D565; Drug: D930 |
| Sequence 2 | Experimental | 1. Period 1: D930 91days
2. Period 2: D565+D930 7days Receives: Drug: D565; Drug: D930 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,ss of D565(Sequence1)
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
Measured: 1day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence1)
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Measured: 8day 0hour ~ 99day 0hour
AUCtau,ss of D565(Sequence2)
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
Measured: 96day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence2)
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Measured: 1day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence1)
The maximum D565 concentration between 0 and τ at steady state
Measured: 1day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence1)
The maximum D930 concentration between 0 and τ at steady state
Measured: 8day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence2)
The maximum D565 concentration between 0 and τ at steady state
Measured: 96day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence2)
The maximum D930 concentration between 0 and τ at steady state
Measured: 1day 0hour ~ 99day 0hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start19 Jan 2022
- Primary completion18 Oct 2022
- Study completion2 Nov 2022
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.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207761
- Sponsor's protocol ID
- A71_05DDI2114
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. 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 Phase 1 Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05207761
- Acronym / sponsor ID
- A71_05DDI2114
- Conditions
- Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 26 Jan 2022 (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.
This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects
Detailed description
To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: D565, Drug: D9301. Period 1: D565 7days 2. Period 2: D565+D930 91days |
| Sequence 2 | Experimental | Drug: D565, Drug: D9301. Period 1: D930 91days 2. Period 2: D565+D930 7days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults volunteers aged between 19 and 55 years old at the time of screening
- Weight ≥ 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2
- Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
- Individuals who are suitable as a subject for this study at the discretion of the researcher as a result of screening tests such as examination, laboratory tests and questionnaires
Key exclusion criteria (26 listed)
- Individuals who have other clinically significant cardiovascular system, respiratory system, liver, renal, nervous system, endocrine system, blood-oncology, psychiatric disorders, urinary system or ophthalmic diseases or have a history
- Individuals who satisfy the following items during the interview or examination
- Individuals who have a history of hypersensitivity to the active ingredient and component of the investigational drug, or to the drug in the same class as the active ingredient
- Individuals with sitting systolic blood pressure ≥ 140 mmHg or ≤ 80 mmHg or sitting diastolic blood pressure ≥ 90 mmHg or ≤ 45 mmHg
- Individuals with the following results at screening test
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 |
|---|---|---|
| D565Q.D. in both eye | Drug | Sequence 1, Sequence 2 |
| D930T.I.D in both eye | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCtau,ss of D565(Sequence1)
Time frame: 1day 0hour ~ 99day 0hour
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
AUCtau,ss of D930(Sequence1)
Time frame: 8day 0hour ~ 99day 0hour
Area under the D930 concentration in blood-time curve from 0 to τ at steady
AUCtau,ss of D565(Sequence2)
Time frame: 96day 0hour ~ 99day 0hour
Area under the D565 concentration in blood-time curve from 0 to τ at steady state
AUCtau,ss of D930(Sequence2)
Time frame: 1day 0hour ~ 99day 0hour
Area under the D930 concentration in blood-time curve from 0 to τ at steady
Cmax,ss of D565(Sequence1)
Time frame: 1day 0hour ~ 99day 0hour
The maximum D565 concentration between 0 and τ at steady state
Cmax,ss of D930(Sequence1)
Time frame: 8day 0hour ~ 99day 0hour
The maximum D930 concentration between 0 and τ at steady state
Cmax,ss of D565(Sequence2)
Time frame: 96day 0hour ~ 99day 0hour
The maximum D565 concentration between 0 and τ at steady state
Cmax,ss of D930(Sequence2)
Time frame: 1day 0hour ~ 99day 0hour
The maximum D930 concentration between 0 and τ at steady state
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 Jan 2023.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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 D565 and D930 in people with Glaucoma, run by Chong Kun Dang Pharmaceutical 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 5 inclusion and 26 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 Jan 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 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?
AUCtau,ss of D565(Sequence1) (time frame: 1day 0hour ~ 99day 0hour). The study lists 8 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 5 Jan 2023.