Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553406
Status:
TERMINATED
Last Update Posted:
2022-02-28
First Post:
2020-09-01
Brief Title:
Safety Tolerability Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex MAC Pulmonary Disease
Sponsor:
Spero Therapeutics
Organization:
Spero Therapeutics
Study Overview
Official Title:
A Randomized Partially Blinded Placebo- and Comparator-Controlled Multicenter Phase 2a Dose Ranging Proof-of-Concept Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex MAC Pulmonary Disease
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision pending resolution of clinical hold with FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the pharmacokinetics PK of SPR719 the active moiety generated from the orally po administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease NTM-PD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None