NCT06697899CompletedPhase 1
TGRX-678 Phase I Oral Pharmacokinetic Study
Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 18 Nov 2024
- Start date
- 24 Nov 2024
- Primary completion date
- 6 Jan 2025
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06697899
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 76
- From 24 Nov 2024 to the primary completion date, 6 Jan 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
- 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
- Received major surgery within 6 months prior to Screening, or with surgical wounds not completely healed
- History of allergic conditions or is allergic to components of the investigational drug
- 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 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
- History of unprotected sexual activities within 1 month prior to screening
- 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
Other illness
- Positive results for Hepatitis B, Hepatitis C, HIV or Syphilis
- History of instrumental cardiovascular diseases
- History of any severe disease or conditions that could affect study results per investigator's discretion
- Having conditions that could affect drug absorption or difficulties to swallow
- History of substance use, or tested positive for drug test during screening
Lab values
- QT interval elongation as indicated by 12-lead ECG test during screening period
Other
- Clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ECG) test
- Having special dietary requirement and cannot comply with food requirement of the study
- Pregnant or breastfeeding female, or tested positive in pregnancy test
- 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
- Any reasons that is deemed unsuitable for study participation as determined by investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.