NCT06986772CompletedPhase 1
TGRX-678 Pharmacokinetic Mass Balance
[14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 15 May 2025
- Start date
- 7 Jul 2025
- Primary completion date
- 17 Aug 2025
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06986772
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 7 Jul 2025 to the primary completion date, 17 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- usage of any inducers or inhibitors for drug metabolism enzymes (especially CYP3A4) within 30 days of screening
- 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
- 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
- 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
- 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
Other illness
- positive test results on hepatitis B surface antigen/ E antigen, hepatitis C antibody, HIV antigen/antibody or syphylus antibody
- 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
- have hemorrhoids; have history of or is having conditions that cause bloody feces, irritable bowel syndrome, or inflammatory bowel disease
- 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
- Any conditions that the investigator deemed unfit for the study
Lab values
- 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
- usage of any prescriptional drug, OTC drug, herbal medicine, traditional Chinese medicine, or food supplements (i.e., vitamins, calcium) within 14 days of screening
Other
- abnornal and of clinical significance results on eye exam
- 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
- 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
- Having special dietary requirements and unable to follow the uniform dietary plan in the study
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.