NCT03926182

Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers

A Randomized, Open Label, Single Center, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Volunteers in the Fasted State or Following a High Fat Meal

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers in Fasting State or Following a High Fat Meal

Detailed description

This is a single center, randomized, open label, single dose, two periods crossover study in healthy male volunteers. The volunteers will be randomly distributed into two groups (fasted-fed and fed-fasted groups). Any volunteer will be administrated once in each treatment period, the interval time of two treatment periods is 22 days (the interval time is no longer than 30 days).

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	AST2818 Tablets	AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
DRUG	AST2818 Tablets	AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.

Timeline

• Start date: 2019-02-19
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2019-04-24
• Last updated: 2020-01-06

Locations

1 site across 1 country: China