TGRX-326 Phase I Oral Pharmacokinetic Study

Shenzhen TargetRx

Status and phase: Not yet enrolling; Phase 1

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: TGRX-678

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06697899

TGRX-678-1002

Details and patient eligibility

About

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Fasting

Experimental group

Description:

Participants take TGRX-678 under fasting state

Treatment:

Drug: TGRX-678

Low-fat Diet

Experimental group

Description:

Participants take TGRX-678 after low-fat meal intake

Treatment:

Drug: TGRX-678

High-fat Diet

Experimental group

Description:

Participants take TGRX-678 after high-fat meal intake

Treatment:

Drug: TGRX-678