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CompletedNCT06697899Updated May 16, 2025

TGRX-678 Phase I Oral Pharmacokinetic Study

A Phase 1 interventional study of TGRX-678 in Chronic Myeloid Leukemia, sponsored by Shenzhen TargetRx, Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Shenzhen TargetRx, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Myeloid Leukemia
03

In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's enrollment of 76 is above the median of 44 across 743 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

Shenzhen TargetRx, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Fasting

    Participants take TGRX-678 under fasting state

    Drug: TGRX-678

  • Experimental
    Low-fat Diet

    Participants take TGRX-678 after low-fat meal intake

    Drug: TGRX-678

  • Experimental
    High-fat Diet

    Participants take TGRX-678 after high-fat meal intake

    Drug: TGRX-678

Interventions

  • DrugTGRX-678

    All participants are given TGRX-678 orally at 240 mg

06

What researchers measure

Primary outcomes

  1. Plasma Tmax

    Time to maximum concentration (Tmax) of TGRX-678 measured in plasma

    Time frame: During Treatment period (Day 1 to Day 43)

  2. Plasma Tlag

    Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration

    Time frame: During Treatment period (Day 1 to Day 43)

  3. Plasma Cmax

    Maximum concentration (Cmax) of TGRX-678 measured in plasma

    Time frame: During Treatment period (Day 1 to Day 43)

  4. 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

    Time frame: During Treatment period (Day 1 to Day 43)

  5. Plasma AUC(0-inf)

    Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma

    Time frame: During Treatment period (Day 1 to Day 43)

  6. 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.

    Time frame: During Treatment period (Day 1 to Day 43)

  7. Half Life (T1/2)

    Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration

    Time frame: During Treatment period (Day 1 to Day 43)

  8. Plasma volume of distribution (Vz/F)

    Apparent volume of distribution of TGRX-678 in plasma

    Time frame: During Treatment period (Day 1 to Day 43)

  9. Plasma clearance (CL/F)

    Apparent clearance of TGRX-678 in plasma

    Time frame: During Treatment period (Day 1 to Day 43)

Secondary outcomes

  1. Adverse Events (AE)

    To record adverse events to participants during study participation

    Time frame: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)

07

Study locations

1 site
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06697899
Lead sponsor
Shenzhen TargetRx, Inc.
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Sponsor
First posted
Nov 20, 2024
Start date
Nov 24, 2024
Primary completion
Jan 6, 2025
Completion
Feb 20, 2025
Last update
May 16, 2025

Study contacts

Juan Li, MD
principal investigator · Nanjing Drug Tower Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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