Leukemia drug TGRX-678 gets a body scan: tiny study tracks its journey
NCT ID NCT06986772
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 study gave 6 healthy Chinese men a single dose of the leukemia drug TGRX-678 to see how the body absorbs, breaks down, and gets rid of it. Researchers measured radioactivity in blood, urine, and stool to map the drug's path. No treatment was given—just understanding how the drug behaves.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TGRX-678 (a tyrosine kinase inhibitor for chronic myeloid leukemia)
- What this could lead to
- If successful, this study will help doctors understand how TGRX-678 moves through the body and how it is eliminated, which can guide future dosing and safety decisions.
- What could go wrong
- This is a very early, small study in just 6 healthy men, not patients. It is designed to measure drug processing, not to test effectiveness or safety for treating leukemia.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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