Irritable Bowel SyndromePhase 1NCT01633723
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
A Phase 1 study testing DA-6886 in people with Irritable Bowel Syndrome, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- DA-6886
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Apr 2014
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 ~ 45 years old
- 27kg/m2 ≥ BMI ≥ 20kg/m2
- Healthy Male
- Informed consent
Who cannot join
- Clinically significant medical history
- smokers
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- QTcB > 450msec
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- DA-6886, Placebo of DA-6886
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-6886Drug
single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation)
multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)
Placebo of DA-6886Drug
DA-6886 placebo
| Study group | Role | What they receive |
|---|---|---|
| DA-6886 | Experimental | Not described Receives: Drug: DA-6886 |
| DA-6886 placebo | Placebo comparator | Not described Receives: Drug: Placebo of DA-6886 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety
- Adverse Events
- Laboratory Results
- Vital sign, Physical Examination, EKG
Measured: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
Secondary outcomes (1)
Pharmacokinetics and Pharmacodynamics
Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
Measured: up to 48 hours after last dosing of DA-6886
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 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
- NCT01633723
- Sponsor's protocol ID
- DA6886_IBS_I
- Status last verified
- Apr 2021
- First submitted
- 2 Jul 2012
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01633723
- Acronym / sponsor ID
- DA6886_IBS_I
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jul 2012 (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.
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-6886 | Experimental | Drug: DA-6886 |
| DA-6886 placebo | Placebo comparator | Drug: Placebo of DA-6886 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20 ~ 45 years old
- 27kg/m2 ≥ BMI ≥ 20kg/m2
- Healthy Male
- Informed consent
Key exclusion criteria (6 listed)
- Clinically significant medical history
- smokers
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- QTcB > 450msec
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-6886single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation) multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation) | Drug | DA-6886 |
| Placebo of DA-6886DA-6886 placebo | Drug | DA-6886 placebo |
Primary outcome
Assessment of safety
Time frame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG
1 secondary outcome
Pharmacokinetics and Pharmacodynamics
Time frame: up to 48 hours after last dosing of DA-6886
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 15 Apr 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.
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-6886 in people with Irritable Bowel Syndrome, 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 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 15 Apr 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. Some participants in this study may receive a placebo. 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?
Assessment of safety (time frame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)). 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 15 Apr 2021.