Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT03291158
Status:
WITHDRAWN
Last Update Posted:
2023-09-21
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV
Sponsor:
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Open-Label Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Minocin (Minocylcine) for Injection
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for injection in healthy adult subjects.
Detailed Description:
The purpose of this study is to evaluate the safety of Minocin IV and measure plasma, epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.
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?:
False
Is an FDA AA801 Violation?: