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TGRX-326 Pharmacokinetic Drug Interaction - Trial NCT06294561

Access comprehensive clinical trial information for NCT06294561 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shenzhen TargetRx, Inc. and is currently Recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 32 participants.

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NCT06294561
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06294561
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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

Study Focus

Itraconazole+TGRX-326

Interventional

drug

Sponsor & Location

Shenzhen TargetRx, Inc.

Nanjing, China

Timeline & Enrollment

Phase 1

Mar 04, 2024

Jun 30, 2024

32 participants

Primary Outcome

Plasma Tmax,Plasma Cmax,Plasma AUC(0-t),Plasma AUC(0-inf),T1/2,Plasma volume of distribution (Vz/F),Plasma clearance (CL/F)

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.

ICD-10 Classifications

Secondary malignant neoplasm of lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06294561

Non-Device Trial