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
Overview
- Phase
- Phase 1
- Intervention
- DA-8010
- Conditions
- Overactive Bladder
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 110
- Primary Endpoint
- Safety and Tolerability
- Last Updated
- 9 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Active in Group A1~A7
In each of Groups A1 to A7, 8 subjects will receive DA-8010.
Intervention: DA-8010
Placebo in Group A1~A7
In each of Groups A1 to A7, 2 subjects will receive placebo.
Intervention: Placebo
Active in Group B1~B4
In each of Groups B1 to B4, 8 subjects will receive DA-8010.
Intervention: DA-8010
Placebo in Group B1~B4
In each of Groups B1 to B4, 2 subjects will receive placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)