A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
- Registration Number
- NCT02821312
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo in Group A1~A7 Placebo In each of Groups A1 to A7, 2 subjects will receive placebo. Active in Group B1~B4 DA-8010 In each of Groups B1 to B4, 8 subjects will receive DA-8010. Placebo in Group B1~B4 Placebo In each of Groups B1 to B4, 2 subjects will receive placebo. Active in Group A1~A7 DA-8010 In each of Groups A1 to A7, 8 subjects will receive DA-8010.
- Primary Outcome Measures
Name Time Method Safety and Tolerability 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 Outcome Measures
Name Time Method 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