Clinical trial · Interventional
TGRX-326 Pharmacokinetic Drug Interaction
An Open-label, Two-cycle, Single Sequence, Self-controlled Study Evaluating Effects of Oral Itraconazole or Efavirenz on Pharmacokinetic Profiles of TGRX-326
NCT06294561CI-TRIAL-00078311completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efavirenz+TGRX-326 | Drug | — | UNRESOLVED |
| Itraconazole+TGRX-326 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Itraconazole
- description
- healthy subjects will be given Itraconazole 200 mg orally with TGRX-326 60 mg
- interventionNames
- Drug: Itraconazole+TGRX-326
- type
- EXPERIMENTAL
- label
- Efavirenz
- description
- healthy subjects will be given Efavirenz 600 mg orally with TGRX-326 60 mg
- interventionNames
- Drug: Efavirenz+TGRX-326
Primary outcomes (7)
- measure
- Plasma Tmax
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.