Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-04 @ 4:39 PM
Study NCT ID:
NCT03483506
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study in Healthy Men Tests How the Body Takes up BI 1467335
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Single-arm Multiple Dose Trial to Investigate Pharmacokinetics and Absolute Bioavailability of BI 1467335 Administered as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [C-14] BI 1467335 After Single and Multiple Oral Doses in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2021-06
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 primary objective of this trial is to investigate the absolute bioavailability of BI 1467335 with an intravenous microdose formulation containing labelled \[C-14\] BI 1467335 and an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.
The secondary objective is the evaluation of additional pharmacokinetic parameters following the two treatments.
The secondary objective is the evaluation of additional pharmacokinetic parameters following the two treatments.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-003853-41 | EUDRACT_NUMBER | None | View |