Clinical trial NCT06438367: TGRX-326 Pharmacokinetic Mass Balance
Official title: Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Shenzhen TargetRx, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2024-05-31
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urine radioactivity
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Fecal radioactivity
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Plasma AUC (Area under curve) percentage
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Urine %Dose
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Fecal %Dose
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Plasma Cmax
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
measure: Plasma Tmax
timeFrame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Secondary outcomes:
measure: Adverse events/serious adverse events
timeFrame: From screening through completion of study, an average of 1 to 1.5 months.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: