TGRX-678 Pharmacokinetic Mass Balance

NCT ID: NCT06986772

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2025-08-25

Brief 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.

Conditions

Chronic Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TGRX-678

healthy male subjects will be given 240mg/250uCi\[14C\]TGRX-678 in suspension

Group Type: EXPERIMENTAL

[14C]TGRX-678

Intervention Type: DRUG

Healthy subjects will be given TGRX-678 240 mg orally on day 1.

Interventions

[14C]TGRX-678

Healthy subjects will be given TGRX-678 240 mg orally on day 1.

Intervention Type: DRUG

Eligibility Criteria

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
• habitutory constipation or diarrhea
• alcohol abuse, or frequent use of alcohol within 6 months of screening
• smoking of more than 5 cigarettes per day within 3 months of screening, or habitutory use of nicotine products and cannot quit during study
• drug abuse, or use of soft drug (marajuana) within 3 months of screening, or use of hard drug (phenylamine or PCP type drugs) within 1 year of screening, or tested positive in urine drug test during screening
• habitutory use of grape fruit juice, or overuse of tea, coffee or caffeinated drugs, and cannot quit during study
• long-term occupational exposure to radioactive conditions, or have history of significant radioactive substance exposure or participated in clinical study using radioactive-labeled drugs within 1 year of current study
• 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; received blood donation within 1 months of study, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shenzhen TargetRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyan Miao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

TGRX-678-1003

Identifier Type: -

Identifier Source: org_study_id