TGRX-326 Pharmacokinetic Mass Balance

NCT ID: NCT06438367

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2024-07-21

Brief Summary

This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

Detailed Description

This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: TGRX-326

healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension

Group Type: EXPERIMENTAL

[14C]TGRX-326

Intervention Type: DRUG

Healthy subjects will be given TGRX-326 60 mg orally on day 1.

Interventions

[14C]TGRX-326

Healthy subjects will be given TGRX-326 60 mg orally on day 1.

Intervention Type: DRUG

Other Intervention Names

TGRX-326

Eligibility Criteria

Inclusion Criteria

• Healthy adult males
• Age between 18 and 45 years old (both limits included)
• Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
• Willing to consent
• Able to communicate with investigator and complete study according to study protocol

Exclusion Criteria

• Clinically significant results from comprehensive physical and clinical examinations
• Positive results on hepatitis, HIV or syphilis
• Clinically significant results from eye examination
• Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
• Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
• Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
• Presence of any condition that could affect drug absorption
• Reception of major surgery within 6 months before screening, or surgical wounds not completely healed
• Presence of allergic reactions or may be allergic to ingredients in the investigational drug
• Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
• Habitual congestion or diarrhea
• Alcohol abuse or excessive alcohol consumption within 6 months before screening
• Excessive smoking within 3 months before screening
• Substance abuse or positive results on urine substance test
• Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
• History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies
• Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
• Participation in any other clinical studies within 3 months before screening
• Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
• Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
• Blood donation or blood loss of > 400 ml within 3 months before screening; blood donation or blood loss of > 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion
• Having special dietary requirements and unable to follow the uniform dietary plan in the study
• Any conditions that the investigator deemed unfit for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shenzhen TargetRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyan Miao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

TGRX-326-1004

Identifier Type: -

Identifier Source: org_study_id