TGRX-326 Pharmacokinetic Mass Balance

Non Small Cell Lung Cancer Clinical Trial

Official title:

Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438367
• Other study ID #: TGRX-326-1004
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Shenzhen TargetRx, Inc.
• Contact: Haifang Guo, PhD
• Phone: +86-18762407693
• Email: haifang.guo[@]tjrbiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: October 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• [14C]TGRX-326
Healthy subjects will be given TGRX-326 60 mg orally on day 1.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen TargetRx, Inc.	The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine radioactivity	[C14]TGRX-326 radioactivity detected in urine	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Fecal radioactivity	[C14]TGRX-326 radioactivity detected in feces	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Plasma AUC (Area under curve) percentage	percentage of [C14]TGRX-326 radioactivity in plasma	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Urine %Dose	percentage of [C14]TGRX-326 radioactivity in urine	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Fecal %Dose	percentage of [C14]TGRX-326 radioactivity in feces	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Plasma Cmax	Maximum concentration of [C14]TGRX-326 measured in plasma	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Primary	Plasma Tmax	Time to maximum concentration of [C14]TGRX-326 measured in plasma	Day-1 (day before dosing), Day 1 to Day 18 after dosing
Secondary	Adverse events/serious adverse events	to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)	From screening through completion of study, an average of 1 to 1.5 months.