Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT01505894
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Safety, Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. or Bid for 14 Days in Young Healthy and Elderly Healthy Male/Female Volunteers (Randomised, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
Status:
COMPLETED
Status Verified Date:
2023-08
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 was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.
The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers
The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-002369-39 | EUDRACT_NUMBER | EudraCT | View |