NCT05248074

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Abion Inc · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
OTHER	High-fat meal (over 900 kcal)	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.
DRUG	ABN401 (investigational product)	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.

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-02-18
• Completion: 2022-10-18
• First posted: 2022-02-21
• Last updated: 2024-02-20

Locations

1 site across 1 country: South Korea