TGRX-326 Pharmacokinetic Mass Balance

Trial Title: TGRX-326 Pharmacokinetic Mass Balance

NCT ID: NCT06438367

Condition: Non Small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [14C]TGRX-326
Description: Healthy subjects will be given TGRX-326 60 mg orally on day 1.
Arm group label: Experimental: TGRX-326

Other name: TGRX-326

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.

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: June 15, 2024

Completion date: October 15, 2024

Lead sponsor:
Agency: Shenzhen TargetRx, Inc.
Agency class: Industry

Collaborator:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Source: Shenzhen TargetRx, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06438367