## Protocol Section
### Identification Module
**NCT ID:** NCT06438367

**Brief Title:** TGRX-326 Pharmacokinetic Mass Balance

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

#### Organization Study ID Info
**ID:** TGRX-326-1004
#### Organization
**Class:** INDUSTRY
**Full Name:** Shenzhen TargetRx, Inc.
### Status Module
#### Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The First Affiliated Hospital of Soochow University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shenzhen TargetRx, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Non Small Cell Lung Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: [14C]TGRX-326

**Label:** Experimental: TGRX-326

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental: TGRX-326

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

**Name:** [14C]TGRX-326

**Other Names:**

- TGRX-326

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** \[C14\]TGRX-326 radioactivity detected in urine

**Measure:** Urine radioactivity

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

**Description:** \[C14\]TGRX-326 radioactivity detected in feces

**Measure:** Fecal radioactivity

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

**Description:** percentage of \[C14\]TGRX-326 radioactivity in plasma

**Measure:** Plasma AUC (Area under curve) percentage

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

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

**Measure:** Urine %Dose

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

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

**Measure:** Fecal %Dose

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

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

**Measure:** Plasma Cmax

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

**Description:** Time to maximum concentration of \[C14\]TGRX-326 measured in plasma

**Measure:** Plasma Tmax

**Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing

#### Secondary Outcomes

**Description:** to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

**Measure:** Adverse events/serious adverse events

**Time Frame:** From screening through completion of study, an average of 1 to 1.5 months.

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** haifang.guo@tjrbiosciences.com

**Name:** Haifang Guo, PhD

**Phone:** +86-18762407693

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** The First Affiliated Hospital of Soochow University

**Name:** Liyan Miao, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-31
