TGRX-326 Pharmacokinetic Drug Interaction

NCT06294561 | Completed Phase 1

• 1 other identifier: TGRX-326-1003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (7)

• Plasma Tmax

  Time to maximum concentration of TGRX-326 measured in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• Plasma Cmax

  Maximum concentration of TGRX-326 measured in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• Plasma AUC(0-t)

  Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• Plasma AUC(0-inf)

  Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• T1/2

  Plasma half-life of TGRX-326

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• Plasma volume of distribution (Vz/F)

  Apparent volume of distribution of TGRX-326 in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

• Plasma clearance (CL/F)

  Apparent clearance of TGRX-326 in plasma

  Itraconazole group: Day 1, Days 2-6, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Days 2-6, Day 20, Day 21-24 and Day 25 (or last day of dosing)

Secondary Outcomes (2)

• Adverse events/serious adverse events

  through completion of the study, an average of 1 month

• Corrected QT Interval

  At screening; Itraconazole group: Day 1, Days 2-5, Day 11, Days 12-15 and Day 16 (or last day of dosing); Efavirenz group: Day 1, Day 20 and Day 25 (or last day of dosing)

Study Arms (2)

Itraconazole

EXPERIMENTAL

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

Drug: Itraconazole+TGRX-326

Efavirenz

EXPERIMENTAL

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

Drug: Efavirenz+TGRX-326

Interventions

Itraconazole+TGRX-326 DRUG

healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Itraconazole 200 mg with TGRX-326 60 mg orally on day 11

Itraconazole

Efavirenz+TGRX-326 DRUG

healthy subjects will be given TGRX-326 60 mg orally on Day 1, and Efavirenz 600 mg with TGRX-326 60 mg orally on day 20

Efavirenz

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Nanjing Drug Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Juan Li, MD

  Nanjing Drug Tower Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: March 4, 2024
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)