Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT04939467
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers
Sponsor:
Blade Therapeutics
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone When Administered Concurrently in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-04
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:
A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone when Administered Concurrently in Healthy Volunteers
Detailed Description:
This is a single-center, open-label study designed to determine the effect of BLD-0409 on the PK of nintedanib and pirfenidone, all at steady state, and to evaluate the safety and tolerability of BLD-0409 administered with either nintedanib or pirfenidone in healthy adult volunteers
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?:
False
Is an FDA AA801 Violation?: