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Chronic Myeloid LeukemiaPhase 1NCT06986772

TGRX-678 Pharmacokinetic Mass Balance

A Phase 1 study testing [14C]TGRX-678 in people with Chronic Myeloid Leukemia, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 myeloid leukemia. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
[14C]TGRX-678
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
7 Jul 2025to 25 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: [14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults

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.

Read the 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 route of excretion of TGRX-678 using the Carbon-14 labelled isotope of TGRX-678 compound. Safety and pharmacokinetic evaluation will also be conducted.

Being tested
[14C]TGRX-678
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]TGRX-678Drug

    Healthy subjects will be given TGRX-678 240 mg orally on day 1.

Study groups in NCT06986772
Study groupRoleWhat they receive
TGRX-678Experimentalhealthy male subjects will be given 240mg/250uCi[14C]TGRX-678 in suspension
Receives: Drug: [14C]TGRX-678

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine radioactivity

    [C14]TGRX-678 radioactivity detected in urine

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  2. Fecal radioactivity

    [C14]TGRX-678 radioactivity detected in feces

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  3. Plasma AUC (Area under curve) percentage

    percentage of [C14]TGRX-678 radioactivity in plasma

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  4. Urine %Dose

    percentage of [C14]TGRX-678 radioactivity in urine

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  5. Fecal %Dose

    percentage of [C14]TGRX-678 radioactivity in feces

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  6. Plasma Cmax

    Maximum concentration of [C14]TGRX-678 measured in plasma

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  7. Plasma Tmax

    Time to maximum concentration of [C14]TGRX-678 measured in plasma

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

  8. Plasma AUC(0-t)

    Area under curve for TGRX-678 plasma concentration from before dose to last measureable timepoint

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing

Secondary outcomes (1)

  1. Adverse events/serious adverse events

    to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

    Measured: Day-1 (day before dosing), Day 1 to Day 54 after dosing or the day sample collection is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start7 Jul 2025
  3. Primary completion17 Aug 2025
  4. Study completion25 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06986772
Sponsor's protocol ID
TGRX-678-1003
Status last verified
Sep 2025
First submitted
15 May 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]TGRX-678 in people with Chronic Myeloid Leukemia, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine radioactivity (time frame: Day-1 (day before dosing), Day 1 to Day 54 after dosing). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06986772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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