NCT06304805

TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

A Randomized, Open-label, Single-dose, 3-cycle, 6-sequence, Crossover Study Evaluating Food Effect on Pharmacokinetic Profiles of TGRX-326 in Chinese Healthy Subjects and Effect of Drug Specification on Bioavailability in Human

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment

Detailed description

This study is designed as single-center, randomized, open-label, 3-cycle, 6-sequence and crossover design to evaluate 1) food effect on PK profile of TGRX-326; 2) effect of different specifications of TGRX-326 on human bioavailability. Safety for food effect on TGRX-326 and safety for different TGRX-326 specifications were also evaluated.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	cycle 1: treatment drug	for cycle 1 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
DRUG	cycle 1: reference drug	for cycle 1 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
BEHAVIORAL	cycle 1: fasted	for cycle 1 treatment: participants are asked to take the drug fasted
BEHAVIORAL	cycle 1: food	for cycle 1 treatment: participants are asked to take the drug after food intake
DRUG	cycle 2: treatment drug	for cycle 2 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
DRUG	cycle 2: reference drug	for cycle 2 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
BEHAVIORAL	cycle 2: fasted	for cycle 2 treatment: participants are asked to take the drug fasted
BEHAVIORAL	cycle 2: food	for cycle 2 treatment: participants are asked to take the drug after food intake
DRUG	cycle 3: treatment drug	for cycle 3 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
DRUG	cycle 3: reference drug	for cycle 3 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
BEHAVIORAL	cycle 3: fasted	for cycle 3 treatment: participants are asked to take the drug fasted
BEHAVIORAL	cycle 3: food	for cycle 3 treatment: participants are asked to take the drug after food intake

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-01-12
• Completion: 2024-01-19
• First posted: 2024-03-12
• Last updated: 2025-05-18

Locations

1 site across 1 country: China