Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05742594
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Status:
COMPLETED
Status Verified Date:
2023-06
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:
The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 73841937NSC1009 | OTHER | Janssen Research & Development, LLC | View |