Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294561
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-02-28
Brief Title:
TGRX-326 Pharmacokinetic Drug Interaction
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
An Open-label Two-cycle Single Sequence Self-controlled Study Evaluating Effects of Oral Itraconazole or Efavirenz on Pharmacokinetic Profiles of TGRX-326
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitorinducer drugs on pharmacokinetic profiles of TGRX-326 an ALK inhibitor indicated for treatment of Non-small cell lung cancer
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None