HealthyPhase 1NCT04686825
The Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects
A Phase 1 study testing DA-8010 2.5mg (Fasting), DA-8010 2.5mg (Fed) and DA-8010 5mg (Fasting) in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-8010 2.5mg (Fasting), DA-8010 2.5mg (Fed) and DA-8010 5mg (Fasting)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2021to 11 Mar 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteer 19 years to 50 years
- Body weight in the range of 45.0 to 90.0 kg and body mass index in the range of 18 to 30kg/m2
- The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
- The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire
Who cannot join
- Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease or history of such disease
- Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
- Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery)
- Subject who have blood pressure < 90 mmHg or >150 mmHg as systolic or <60 mmHg or >100 mmHg as diastolic
- Subject who have history of drug abuse or Positive in Urine drug screen test
- Subject who are Positivie in Alcohol breath test on screening
Show all 17Show fewer
- Subject who have ETC drug or oriental medicine 2 weeks prior to IP administration or OTC drug or health functional food or vitamins 1 week prior to IP administration
- Subject who have taken a drug that induces or inhibits the drug metabolic enzyme (e.g., barbital) within 30 days prior to IP administration
- Subject who have participated in other clinical trials within 6 months prior to the first administration of the IP
- Subject who have had whole blood transfusion within 2 months or the apheresis within 2 weeks prior to the first administration of the IP
- Subject with a history of regular alcohol intake(>21 units/week , 1 unit = 10 g of pure alcohol) or who are unable to quit alcohol from 3 days prior to the first administration of the IP until out of hospital
- Smoker(excluding who quit smoking 3 months before this clinical trial) or subject who are unable to quit smoking from 3 days prior to first administration of the IP until out of hospital
- Subject who are unable to quit food containing grapefruit from 3 days before first administration of the IP until out of hospital
- Subject who regularly intake caffeine(> 5 units/day) or who are unable to quit caffeine/food containing caffeine from 3 days before first administration of the IP until out of hospital
- Subject with unusual eating habits (continuous vegetarian diet, etc.) or who are unable to consume the entire diet provided in this clinical trial
- Subject who are positive in pregnancy test or pregnant or Lactating women
- Subject who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 4 weeks after the last administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, 4-way Crossover Phase 1 Study to Evaluate the Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects
This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects
- Conditions
- Healthy
- Being tested
- DA-8010 2.5mg (Fasting), DA-8010 2.5mg (Fed), DA-8010 5mg (Fasting), DA-8010 5mg (Fed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8010 2.5mg (Fasting)Drug
Test drug l : DA-8010 2.5mg (Fasting)
DA-8010 2.5mg (Fed)Drug
Test drug ll : DA-8010 2.5mg (Fed)
DA-8010 5mg (Fasting)Drug
Test drug llI : DA-8010 5mg (Fasting)
DA-8010 5mg (Fed)Drug
Test drug lV : DA-8010 5mg (Fed)
| Study group | Role | What they receive |
|---|---|---|
| T1 | Experimental | DA-8010 2.5 mg (Fasting) Receives: Drug: DA-8010 2.5mg (Fasting) |
| T2 | Experimental | DA-8010 2.5 mg (Fed) Receives: Drug: DA-8010 2.5mg (Fed) |
| T3 | Experimental | DA-8010 5 mg (Fasting) Receives: Drug: DA-8010 5mg (Fasting) |
| T4 | Experimental | DA-8010 5 mg (Fed) Receives: Drug: DA-8010 5mg (Fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
PK parameter
Measured: 0~48hours
Area under the plasma concentration versus time curve (AUClast)
PK parameter
Measured: 0~48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start13 Jan 2021
- Primary completion17 Feb 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung Hwan Lee, PhD, Principal investigator, SNUH Clinical Pharmacololgy and Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686825
- Sponsor's protocol ID
- DA8010_DIF_I
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2020
- Last updated
- 26 May 2021
- 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 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 4-way Crossover Phase 1 Study to Evaluate the Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04686825
- Acronym / sponsor ID
- DA8010_DIF_I
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 29 Dec 2020 (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 is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1 | Experimental | Drug: DA-8010 2.5mg (Fasting)DA-8010 2.5 mg (Fasting) |
| T2 | Experimental | Drug: DA-8010 2.5mg (Fed)DA-8010 2.5 mg (Fed) |
| T3 | Experimental | Drug: DA-8010 5mg (Fasting)DA-8010 5 mg (Fasting) |
| T4 | Experimental | Drug: DA-8010 5mg (Fed)DA-8010 5 mg (Fed) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteer 19 years to 50 years
- Body weight in the range of 45.0 to 90.0 kg and body mass index in the range of 18 to 30kg/m2
- The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
- The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire
Key exclusion criteria (17 listed)
- Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease or history of such disease
- Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
- Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery)
- Subject who have blood pressure < 90 mmHg or >150 mmHg as systolic or <60 mmHg or >100 mmHg as diastolic
- Subject who have history of drug abuse or Positive in Urine drug screen 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 |
|---|---|---|
| DA-8010 2.5mg (Fasting)Test drug l : DA-8010 2.5mg (Fasting) | Drug | T1 |
| DA-8010 2.5mg (Fed)Test drug ll : DA-8010 2.5mg (Fed) | Drug | T2 |
| DA-8010 5mg (Fasting)Test drug llI : DA-8010 5mg (Fasting) | Drug | T3 |
| DA-8010 5mg (Fed)Test drug lV : DA-8010 5mg (Fed) | Drug | T4 |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 0~48hours
PK parameter
Area under the plasma concentration versus time curve (AUClast)
Time frame: 0~48hours
PK parameter
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 26 May 2021.
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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.
Seung Hwan Lee, PhD principal investigator
SNUH Clinical Pharmacololgy and Therapeutics
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 DA-8010 2.5mg (Fasting), DA-8010 2.5mg (Fed) and DA-8010 5mg (Fasting) in people with Healthy, run by Dong-A ST Co., Ltd. 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 4 inclusion and 17 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 26 May 2021. 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?
Peak Plasma Concentration (Cmax) (time frame: 0~48hours). 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 26 May 2021.