Status:
COMPLETED
TGRX-678 Pharmacokinetic Mass Balance
Lead Sponsor:
Shenzhen TargetRx, Inc.
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Conditions:
Chronic Myeloid Leukemia
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 myelo...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06986772
Start Date
July 7 2025
End Date
August 25 2025
Last Update
September 4 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006