TGRX-326 Pharmacokinetic Drug Interaction

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.

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