To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers

NCT05248074 | Completed Phase 1

• 1 other identifier: ABN401-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• AUC0-t

  AUC0-t of ABN401

  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

• Cmax

  Cmax of ABN401

  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

Secondary Outcomes (11)

• 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

• 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

• 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

Study Arms (2)

Fasting group

OTHER

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)

Other: High-fat meal (over 900 kcal); Drug: ABN401 (investigational product)

Fed group

OTHER

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

Other: High-fat meal (over 900 kcal); Drug: ABN401 (investigational product)

Interventions

High-fat meal (over 900 kcal) OTHER

High-fat meal (over 900 kcal 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.

Fasting group; Fed group

ABN401 (investigational product) DRUG

The investigational product, ABN401 800 mg (3 x 250 mg + 2 x 25 mg) will be administered orally with approximately 240 mL of water in fasted or fed condition in accordance with the order of IP administration in an allocated sequence.

Fasting group; Fed group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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
• Subjects who have participated and given any other study drugs in other clinical study or bioequivalence study within 6 months prior to the first IP administration (the last day of IP administration is considered the end-of-study).
• Subjects with a past history of drug abuse or a positive urine drug screening test.
• Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals, within 1 month prior to the first IP administration.
• Subjects who have taken any prescribed medications or herbal medicine within 2 weeks or any over-the-counter medications or vitamin supplements within 10 days prior to the first IP administration (except for circumstances considered acceptable with no concerned effect on the pharmacokinetics of the IP at the investigator's discretion).
• Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives or other drugs (such as aspirin, anti-biotics, biguanides, etc.).

Sponsors & Collaborators

• Abion Inc: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, Seowon-gu, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 21, 2022
• Study Start: January 4, 2022
• Primary Completion: February 18, 2022
• Study Completion: October 18, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)