TGRX-326 Pharmacokinetic Mass Balance

NCT06438367 | Completed Phase 1

• 1 other identifier: TGRX-326-1004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (7)

• Urine radioactivity

  \[C14\]TGRX-326 radioactivity detected in urine

  Day-1 (day before dosing), Day 1 to Day 18 after dosing

• Fecal radioactivity

  \[C14\]TGRX-326 radioactivity detected in feces

  Day-1 (day before dosing), Day 1 to Day 18 after dosing

• 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

• Urine %Dose

  percentage of \[C14\]TGRX-326 radioactivity in urine

  Day-1 (day before dosing), Day 1 to Day 18 after dosing

• Fecal %Dose

  percentage of \[C14\]TGRX-326 radioactivity in feces

  Day-1 (day before dosing), Day 1 to Day 18 after dosing

• Plasma Cmax

  Maximum concentration of \[C14\]TGRX-326 measured in plasma

  Day-1 (day before dosing), Day 1 to Day 18 after dosing

• 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 Outcomes (1)

• Adverse events/serious adverse events

  From screening through completion of study, an average of 1 to 1.5 months.

Study Arms (1)

Experimental: TGRX-326

EXPERIMENTAL

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

Drug: [14C]TGRX-326

Interventions

[14C]TGRX-326 DRUG

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

Also known as: TGRX-326

Experimental: TGRX-326

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Liyan Miao, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: June 26, 2024
• Primary Completion: July 8, 2024
• Study Completion: July 21, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)