An Open-label, Two-cycle, Single Sequence, Self-controlled Study Evaluating Effects of Oral Itraconazole or Efavirenz on Pharmacokinetic Profiles of TGRX-326

TGRX-326-1003

This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

2024-03-04

2024-04-30

2024-06-30

Recruiting

Early phase I

32

Inclusion Criteria: * healthy subject; male or female * Age between 18 and 45 (inclusive) * body mass index (BMI) between 19.0 and 26.0 (inclusive) * agree to consent * able to communicate with investigator well and complete the study according to study protocol Exclusion Criteria: * abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.) * any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody * prolongation in QT interval * use of substance that affects CYP3A4 enzyme activity with 30 days before screening * use of any drug within 14 days of test article administration * use of any investigational drug or participation of any clinical study within 3 months before screening * vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period * history of cardiovascular diseases * history of mental conditions including depression, aggressive behaviours, epilepsy, etc. * history of major surgery within 6 months before screen, or have unhealed surgical wounds. * any clinically significant conditions that investigator believes could affect study outcomes * history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study * daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study * history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of \> 0.0 mg/dl at screening * history of substance abuse, or positive drug results at screening * history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice * positive pregnancy test results, or pregnant/breast-feeding females * history of unprotected sexual activities within 1 month before screening * have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study * history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study * any reasons that is deemed unsuitable for study participation as determined by investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

2024-03-08