TGRX-326 Pharmacokinetic Drug Interaction
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.
- EligibilityCriteria: 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 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult