TGRX-326 Pharmacokinetic Mass Balance

Shenzhen TargetRx

Status and phase

Completed

Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: [14C]TGRX-326

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06438367

TGRX-326-1004

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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