An Open-label, Randomized, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- High-fat meal (over 900 kcal)
- Conditions
- Solid Tumor
- Sponsor
- Abion Inc
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- AUC0-t
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This randomized open-label, two-way crossover study is designed to evaluate the safety and pharmacokinetic characteristics of ABN401, and the effect of high-fat meal on the pharmacokinetic profiles of ABN401 and its metabolites in healthy adult volunteers.
Detailed Description
The amount of dose for a single administration is 800 mg, which will be given as three 250 mg tablets and two 25 mg tablets. * Fasting: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) after an overnight fast * Fed: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) in fed condition. High-fat meal (over 900kcal with over 35 percent fat content of total calorie) will be provided prior to IP administration. The IP will then be administered 30 minutes after the subject begins the meal.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects aged over 19 years (inclusive) at the time of screening
- •Subjects weighing at least 50.0 kg with a BMI between 18.0 kg/m2 and 30.0 kg/m2 (inclusive)
- •☞ BMI (body mass index) = {weight (kg) / height (m)2}
- •Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
- •Subjects considered eligible for the study participation in accordance to the results of vital signs, 12-lead ECG, clinical laboratory tests (including hematology, blood chemistry, urinalysis, serology, etc.) and urine drug screening conducted at the time of screening, based on the investigational product (IP) characteristics (In cases of the results outside the NCS range considered due to irregular lifestyle (drinking, night-time shifts, etc.) final decision of inclusion can be made with additional follow-up after modification of the causal lifestyle)
- •Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period
Exclusion Criteria
- •Subjects with any clinically significant hepatic, renal, nervous, psychiatric, respiratory, endocrine, circulatory system, neoplastic, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, or a past medical history of any of the aforementioned conditions.
- •Subjects with a past medical history of gastrointestinal disease (Crohn's disease, ulcers, acute/chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy and hernia repair) which may affect the absorption of the IP.
- •Subjects with clinically significant 12-lead ECG findings including the following results at the time of screening.
- •QTc \> 450 ms
- •PR interval \> 200 ms
- •QRS duration \> 120 ms
- •Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 beat/min or ≥ 100 beat/min, when measured in a seated position without an abrupt change in body position for at least 3 minutes.
- •Subjects with laboratory test results as follows.
- •Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin) values exceeding twice the upper limit of normal.
- •Creatinine values outside the reference ranges or eGFR \< 60 mL/min/1.73m2
Arms & Interventions
Fasting group
Period 1 : Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) after an overnight fast Peroid 2: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) in fed condition. High-fat meal (over 900 kcal)
Intervention: High-fat meal (over 900 kcal)
Fasting group
Period 1 : Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) after an overnight fast Peroid 2: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) in fed condition. High-fat meal (over 900 kcal)
Intervention: ABN401 (investigational product)
Fed group
Peroid 1: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) in fed condition. High-fat meal (over 900 kcal) Period 2: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) after an overnight fast
Intervention: High-fat meal (over 900 kcal)
Fed group
Peroid 1: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) in fed condition. High-fat meal (over 900 kcal) Period 2: Single oral administration of ABN401 800 mg (3 x 250 mg + 2 x 25 mg) after an overnight fast
Intervention: ABN401 (investigational product)
Outcomes
Primary Outcomes
AUC0-t
Time Frame: Pre-dose (0 hour), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose
AUC0-t of ABN401
Cmax
Time Frame: Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose
Cmax of ABN401
Secondary Outcomes
- AUCinf(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- Tmax(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- t1/2(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- CL/F(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- Vd/F(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24h hours (h)post-dose)
- AUC0-t(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- Metabolic ratio(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)
- Cmax(Pre-dose (0 h), 0.25 hours (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, and 24 hours (h) post-dose)