Clinical trial · Interventional
TGRX-678 Pharmacokinetic Mass Balance
[14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults
NCT06986772CI-TRIAL-00094505completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]TGRX-678 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TGRX-678
- description
- healthy male subjects will be given 240mg/250uCi\[14C\]TGRX-678 in suspension
- interventionNames
- Drug: [14C]TGRX-678
Primary outcomes (8)
- measure
- Urine radioactivity
- timeFrame
- Day-1 (day before dosing), Day 1 to Day 54 after dosing
- description
- \[C14\]TGRX-678 radioactivity detected in urine
- measure
- Fecal radioactivity
- timeFrame
- Day-1 (day before dosing), Day 1 to Day 54 after dosing
- description
- \[C14\]TGRX-678 radioactivity detected in feces
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.