Chronic Myeloid LeukemiaPhase 1NCT06697899
TGRX-678 Phase I Oral Pharmacokinetic Study
A Phase 1 study testing TGRX-678 in people with Chronic Myeloid Leukemia, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
Trial summary
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- TGRX-678
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2024to 20 Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants, male or female
- Age between 18 and 45 (both inclusive)
- Body Weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m^2 (both inclusive)
- Signing informed concent at own will
- Able to communicate with researcher and able to complete study per protocol instruction
Who cannot join
- Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
- Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
- QT interval elongation as indicated by 12-lead ECG test during screening period
- Use of any medication that could impact CYP3A4 enzyme activities within 30 days prior to Screening period
- Use of any medication within 14 days of first dose of the investigational drug
- Vaccinated within 30 days of first dose of the investigational drug, or planning to be vaccinated during study
Show all 21Show fewer
- History of instrumental cardiovascular diseases
- Received major surgery within 6 months prior to Screening, or with surgical wounds not completely healed
- History of any severe disease or conditions that could affect study results per investigator's discretion
- History of allergic conditions or is allergic to components of the investigational drug
- Having conditions that could affect drug absorption or difficulties to swallow
- History of smoking of >5 cigarettes per day within 3 months prior to screening, or cannot stop tabacco using during study
- History of alcohol abuse, or alcohol consumption of >14 unit alcohol within 3 months prior to screening
- History of substance use, or tested positive for drug test during screening
- History of specific food (i.e., grapefruit, mango) consumption, or/and large tea/coffee/caffeinated drink/grapefruit product intake of > 8 cups per day, within 2 weeks prior to first dose
- Having special dietary requirement and cannot comply with food requirement of the study
- Pregnant or breastfeeding female, or tested positive in pregnancy test
- History of unprotected sexual activities within 1 month prior to screening
- Having plans for pregnancy during the study and within 6 months after study completion; or not agreeing to take strict contraceptive measures during study and within 6 months after study completion
- History of blood loss/ blood donation of ≥ 400 mL within 3 months prior to screening, or planning to donate blood within 1 month after study completion
- Any reasons that is deemed unsuitable for study participation as determined by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
Read the detailed description
This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- 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.
TGRX-678Drug
All participants are given TGRX-678 orally at 240 mg
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Participants take TGRX-678 under fasting state Receives: Drug: TGRX-678 |
| Low-fat Diet | Experimental | Participants take TGRX-678 after low-fat meal intake Receives: Drug: TGRX-678 |
| High-fat Diet | Experimental | Participants take TGRX-678 after high-fat meal intake Receives: Drug: TGRX-678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Tmax
Time to maximum concentration (Tmax) of TGRX-678 measured in plasma
Measured: During Treatment period (Day 1 to Day 43)
Plasma Tlag
Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration
Measured: During Treatment period (Day 1 to Day 43)
Plasma Cmax
Maximum concentration (Cmax) of TGRX-678 measured in plasma
Measured: During Treatment period (Day 1 to Day 43)
Plasma AUC(0-t)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-678 as measured in plasma
Measured: During Treatment period (Day 1 to Day 43)
Plasma AUC(0-inf)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma
Measured: During Treatment period (Day 1 to Day 43)
AUC(%Extrap)
Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-678 plasma concentration over time curve.
Measured: During Treatment period (Day 1 to Day 43)
Half Life (T1/2)
Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration
Measured: During Treatment period (Day 1 to Day 43)
Plasma volume of distribution (Vz/F)
Apparent volume of distribution of TGRX-678 in plasma
Measured: During Treatment period (Day 1 to Day 43)
Plasma clearance (CL/F)
Apparent clearance of TGRX-678 in plasma
Measured: During Treatment period (Day 1 to Day 43)
Secondary outcomes (1)
Adverse Events (AE)
To record adverse events to participants during study participation
Measured: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start24 Nov 2024
- Primary completion6 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Li, MD, Principal investigator, Nanjing Drug Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697899
- Sponsor's protocol ID
- TGRX-678-1002
- Status last verified
- May 2025
- First submitted
- 18 Nov 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
- ClinicalTrials.gov ID
- NCT06697899
- Acronym / sponsor ID
- TGRX-678-1002
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
Detailed description
This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Drug: TGRX-678Participants take TGRX-678 under fasting state |
| Low-fat Diet | Experimental | Drug: TGRX-678Participants take TGRX-678 after low-fat meal intake |
| High-fat Diet | Experimental | Drug: TGRX-678Participants take TGRX-678 after high-fat meal intake |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy participants, male or female
- Age between 18 and 45 (both inclusive)
- Body Weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m^2 (both inclusive)
- Signing informed concent at own will
- Able to communicate with researcher and able to complete study per protocol instruction
Key exclusion criteria (21 listed)
- Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
- Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
- QT interval elongation as indicated by 12-lead ECG test during screening period
- Use of any medication that could impact CYP3A4 enzyme activities within 30 days prior to Screening period
- Use of any medication within 14 days of first dose of the investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGRX-678All participants are given TGRX-678 orally at 240 mg | Drug | Fasting, High-fat Diet, Low-fat Diet |
Primary outcome
Plasma Tmax
Time frame: During Treatment period (Day 1 to Day 43)
Time to maximum concentration (Tmax) of TGRX-678 measured in plasma
Plasma Tlag
Time frame: During Treatment period (Day 1 to Day 43)
Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration
Plasma Cmax
Time frame: During Treatment period (Day 1 to Day 43)
Maximum concentration (Cmax) of TGRX-678 measured in plasma
Plasma AUC(0-t)
Time frame: During Treatment period (Day 1 to Day 43)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-678 as measured in plasma
Plasma AUC(0-inf)
Time frame: During Treatment period (Day 1 to Day 43)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma
AUC(%Extrap)
Time frame: During Treatment period (Day 1 to Day 43)
Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-678 plasma concentration over time curve.
Half Life (T1/2)
Time frame: During Treatment period (Day 1 to Day 43)
Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration
Plasma volume of distribution (Vz/F)
Time frame: During Treatment period (Day 1 to Day 43)
Apparent volume of distribution of TGRX-678 in plasma
Plasma clearance (CL/F)
Time frame: During Treatment period (Day 1 to Day 43)
Apparent clearance of TGRX-678 in plasma
1 secondary outcome
Adverse Events (AE)
Time frame: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Li, MD principal investigator
Nanjing Drug Tower Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 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 21 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 16 May 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?
Plasma Tmax (time frame: During Treatment period (Day 1 to Day 43)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.