TGRX-326 Pharmacokinetic Drug Interaction

Shenzhen TargetRx

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Itraconazole+TGRX-326; Drug: Efavirenz+TGRX-326

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06294561

TGRX-326-1003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Itraconazole

Experimental group

Description:

healthy subjects will be given Itraconazole 200 mg orally with TGRX-326 60 mg

Treatment:

Drug: Itraconazole+TGRX-326

Efavirenz

Experimental group

Description:

healthy subjects will be given Efavirenz 600 mg orally with TGRX-326 60 mg

Treatment:

Drug: Efavirenz+TGRX-326