TGRX-326 Pharmacokinetic Mass Balance

February 19, 2025 updated by: Shenzhen TargetRx, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: TGRX-326
healthy subjects will be given 60mg/100uCi[14C]TGRX-326 in suspension
Drug: [14C]TGRX-326
Healthy subjects will be given TGRX-326 60 mg orally on day 1.
Other Names:
  • TGRX-326

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urine radioactivity
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
[C14]TGRX-326 radioactivity detected in urine
Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal radioactivity
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
[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
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in plasma
Day-1 (day before dosing), Day 1 to Day 18 after dosing
Urine %Dose
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in urine
Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal %Dose
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in feces
Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Cmax
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Maximum concentration of [C14]TGRX-326 measured in plasma
Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Tmax
Time Frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Time to maximum concentration of [C14]TGRX-326 measured in plasma
Day-1 (day before dosing), Day 1 to Day 18 after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events/serious adverse events
Time Frame: From screening through completion of study, an average of 1 to 1.5 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen TargetRx, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Soochow University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liyan Miao, MD, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TGRX-326-1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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