Clinical trial · Interventional
TGRX-678 Phase I Oral Pharmacokinetic Study
Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
NCT06697899CI-TRIAL-00089795completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TGRX-678 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Fasting
- description
- Participants take TGRX-678 under fasting state
- interventionNames
- Drug: TGRX-678
- type
- EXPERIMENTAL
- label
- Low-fat Diet
- description
- Participants take TGRX-678 after low-fat meal intake
- interventionNames
- Drug: TGRX-678
- type
- EXPERIMENTAL
- label
- High-fat Diet
- description
- Participants take TGRX-678 after high-fat meal intake
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.