tgrx-326 pharmacokinetic drug interaction

Conditions: Non Small Cell Lung Cancer

Summary: 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.

this study is designed as an open-label, single sequence, self-controlled study. the study will be conducted for 2 cycles, 10 days per cycle. itraconazole, a cyp3a inhibitor, and efavirenz, a cyp3a inducer, will be administrated orally with tgrx-326 to evaluate the effect of these drugs on the pharmacokinetic profiles of tgrx-326. pharmacokinetic parameters will be evaluated as primary endpoints. safety evaluation will also be conducted.

Eligibility criteria:
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