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COMPLETEDPHASE1

TGRX-678 Pharmacokinetic Mass Balance

[14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults

NCT06986772•Shenzhen TargetRx Co., Ltd.

Summary

This is a pharmacokinetic study for \[14C\]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.

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-678 using the Carbon-14 labelled isotope of TGRX-678 compound. Safety and pharmacokinetic evaluation will also be conducted.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adult males
•age between 18 and 45 (both included) years old
•body weight index between 19.0 and 26.0 kg/m2 (both included, and body weight not lower than 50 kg
•can volunteeringly consent
•can communicate well with investigators and complete study according to protocol requirements

Exclusion Criteria

•abnormal and of clinical significance results on physical exam, regular laboratory tests, thyroid function, anal check, chest x-ray, abdominal ultrasound check or 12-lead ECG
•positive test results on hepatitis B surface antigen/ E antigen, hepatitis C antibody, HIV antigen/antibody or syphylus antibody
•abnornal and of clinical significance results on eye exam
•usage of any inducers or inhibitors for drug metabolism enzymes (especially CYP3A4) within 30 days of screening
•usage of any prescriptional drug, OTC drug, herbal medicine, traditional Chinese medicine, or food supplements (i.e., vitamins, calcium) within 14 days of screening
•history of any clinically significant serious diseases or any conditions that at investigator's discretion may affect study results
•have condition that may affect drug absoption
•received major surgery or with un-healed surgical wounds within 6 months of screening
•have allergies to at least 2 substances or at investigator's discretion may be allergic to investigational drug or any excipients
•have hemorrhoids; have history of or is having conditions that cause bloody feces, irritable bowel syndrome, or inflammatory bowel disease
+13 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

July 7, 2025

Primary Completion Date

August 17, 2025

Completion Date

August 25, 2025

Last Updated

September 4, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Myeloid Leukemia

Interventions

[14C]TGRX-678

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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TGRX-678 Pharmacokinetic Mass Balance

Inclusion Criteria

Exclusion Criteria

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies