Clinical trial NCT06697899: TGRX-678 Phase I Oral Pharmacokinetic Study
Official title: Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Shenzhen TargetRx, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2024-11-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Tmax
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma Tlag
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma Cmax
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma AUC(0-t)
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma AUC(0-inf)
timeFrame: During Treatment period (Day 1 to Day 43)
measure: AUC(%Extrap)
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Half Life (T1/2)
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma volume of distribution (Vz/F)
timeFrame: During Treatment period (Day 1 to Day 43)
measure: Plasma clearance (CL/F)
timeFrame: During Treatment period (Day 1 to Day 43)
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Drug Tower Hospital
name: Juan Li, MD
role: PRINCIPAL_INVESTIGATOR
References: