HealthyPhase 1NCT05991401
Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
A Phase 1 study testing DA-8010 5mg, Clarithromycin 500mg and Rifampicin 600mg in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults. 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 5mg, Clarithromycin 500mg and Rifampicin 600mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Aug 2023to 17 Nov 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteer 19 years to 50 years
- Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
- In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
- 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, sexual disorder, ophthalmologic or history of such disease
- Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
- Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
- Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
- Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
- Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
- Conditions
- Healthy
- Being tested
- DA-8010 5mg, Clarithromycin 500mg, Rifampicin 600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8010 5mgDrug
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
Clarithromycin 500mgDrug
[Period 2] DA-8010 5mg, Clarithromycin 500mg
Rifampicin 600mgDrug
[Period 3] DA-8010 5mg, Rifampicin 600mg
| Study group | Role | What they receive |
|---|---|---|
| Period 1 or 2 or 3 | Experimental | [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg Receives: Drug: DA-8010 5mg; Drug: Clarithromycin 500mg; Drug: Rifampicin 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration of DA-8010 (Cmax)
Measured: 0~48hours
Area under the plasma concentration versus time curve of DA-8010 (AUClast)
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 posted14 Aug 2023
- Study start18 Aug 2023
- Primary completion6 Nov 2023
- Study completion17 Nov 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- 3-period
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991401
- Sponsor's protocol ID
- DA8010_DICR_I
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2023
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05991401
- Acronym / sponsor ID
- DA8010_DICR_I
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 14 Aug 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.
This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3-period
| Arm | Type | Receives |
|---|---|---|
| Period 1 or 2 or 3 | Experimental | Drug: DA-8010 5mg, Drug: Clarithromycin 500mg, Drug: Rifampicin 600mg[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult volunteer 19 years to 50 years
- Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
- In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
- 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 (6 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, sexual disorder, ophthalmologic or history of such disease
- Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
- Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
- Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
- Subject who have history of drug/alcohol 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 5mg[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg | Drug | Period 1 or 2 or 3 |
| Clarithromycin 500mg[Period 2] DA-8010 5mg, Clarithromycin 500mg | Drug | Period 1 or 2 or 3 |
| Rifampicin 600mg[Period 3] DA-8010 5mg, Rifampicin 600mg | Drug | Period 1 or 2 or 3 |
Primary outcome
Peak Plasma Concentration of DA-8010 (Cmax)
Time frame: 0~48hours
Area under the plasma concentration versus time curve of DA-8010 (AUClast)
Time frame: 0~48hours
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 25 Jan 2024.
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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 DA-8010 5mg, Clarithromycin 500mg and Rifampicin 600mg 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 5 inclusion and 6 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 25 Jan 2024. 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 of DA-8010 (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 25 Jan 2024.