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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.
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Soochow University
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.