Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT05694533
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults
Sponsor:
Indivior Inc.
Organization:
Study Overview
Official Title:
An Open Label, Fixed-sequence Study to Evaluate the Potential CYP3A4 Induction Effect of INDV-2000 Using Oral Midazolam as a Probe in Healthy Adults Participants
Status:
COMPLETED
Status Verified Date:
2024-05
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 investigate the potential for cytochrome P450 (CYP) 3A4 induction after dosing with INDV-2000 via use of midazolam as a probe.
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 |
|---|---|---|---|---|
| UG3DA050308 | NIH | None | https://reporter.nih.gov/quic… | View |