Overactive Bladder
Conditions
Brief 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.
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).
Interventions
DRUGDA-8010
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.
DRUGPlacebo
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.
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) | 48 hours |
| Maximum observed plasma concentration (Cmax) | 48 hours |
| Time of the maximum observed plasma concentration (tmax) | 48 hours |
Contacts
Primary ContactSujin Cho
Outcome results
None listed