Overactive BladderPhase 1NCT02821312
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
A Phase 1 study testing DA-8010 in people with Overactive Bladder, run by Dong-A ST Co., Ltd..
Trial summary
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- DA-8010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.0 and 32.0 kg/m2
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Subjects who do not agree to use a method of acceptable contraception
- Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
- Consume more than 28 or 21 units of alcohol per week if male or female, respective
- Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
- Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
- Systolic blood pressure < 90 mmHg or > 140 mmHg
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- Diastolic blood pressure < 50 mmHg or > 90 mmHg
- Pulse rate < 45 bpm or > 100 bpm
- Positive urine drugs of abuse screen at screening or first admission
- Positive alcohol breath test at screening or first admission
- Positive cotinine test at screening or first admission
- Abnormality in the 12-lead ECG at screening, admission or predose on Day 1
- Subjects who are pregnant, breastfeeding, or lactating
- Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration
- Subjects who have a significant history of drug allergy, as determined by the Investigator
- Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin > ULN at screening or admission
- Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.
Read the detailed description
This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.
In Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.
In Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).
- Conditions
- Overactive Bladder
- Being tested
- DA-8010, Placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8010Drug
Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010.
Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010.
PlaceboDrug
Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010.
Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010.
| Study group | Role | What they receive |
|---|---|---|
| Active in Group A1~A7 | Active comparator | In each of Groups A1 to A7, 8 subjects will receive DA-8010. Receives: Drug: DA-8010 |
| Placebo in Group A1~A7 | Placebo comparator | In each of Groups A1 to A7, 2 subjects will receive placebo. Receives: Drug: Placebo |
| Active in Group B1~B4 | Active comparator | In each of Groups B1 to B4, 8 subjects will receive DA-8010. Receives: Drug: DA-8010 |
| Placebo in Group B1~B4 | Placebo comparator | In each of Groups B1 to B4, 2 subjects will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).
Measured: during 10 days in Part A
Safety and Tolerability
Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).
Measured: during 16 days in Part B
Secondary outcomes (3)
Area under the plasma concentration-time curve (AUC)
Measured: 48 hours
Maximum observed plasma concentration (Cmax)
Measured: 48 hours
Time of the maximum observed plasma concentration (tmax)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jisu Song, Study director, Dong-A ST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821312
- Sponsor's protocol ID
- DA8010_OAB_I
- Status last verified
- Jun 2016
- First submitted
- 19 Jun 2016
- Last updated
- 1 Jul 2016
- 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 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02821312
- Acronym / sponsor ID
- DA8010_OAB_I
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 1 Jul 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.
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.
Detailed description
This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.
In Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.
In Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active in Group A1~A7 | Active comparator | Drug: DA-8010In each of Groups A1 to A7, 8 subjects will receive DA-8010. |
| Placebo in Group A1~A7 | Placebo comparator | Drug: PlaceboIn each of Groups A1 to A7, 2 subjects will receive placebo. |
| Active in Group B1~B4 | Active comparator | Drug: DA-8010In each of Groups B1 to B4, 8 subjects will receive DA-8010. |
| Placebo in Group B1~B4 | Placebo comparator | Drug: PlaceboIn each of Groups B1 to B4, 2 subjects will receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18.0 and 32.0 kg/m2
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (17 listed)
- Subjects who do not agree to use a method of acceptable contraception
- Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
- Consume more than 28 or 21 units of alcohol per week if male or female, respective
- Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
- Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
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-8010Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010. | Drug | Active in Group A1~A7, Active in Group B1~B4 |
| PlaceboPart A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010. | Drug | Placebo in Group A1~A7, Placebo in Group B1~B4 |
Primary outcome
Safety and Tolerability
Time frame: during 10 days in Part A
Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).
Safety and Tolerability
Time frame: during 16 days in Part B
Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).
3 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: 48 hours
Maximum observed plasma concentration (Cmax)
Time frame: 48 hours
Time of the maximum observed plasma concentration (tmax)
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- 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.
Jisu Song study director
Dong-A ST
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-8010 in people with Overactive Bladder, run by Dong-A ST Co., Ltd..
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 2 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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujin Cho (8229208329, csjin@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: during 10 days in Part A). 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 1 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.