Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02950805
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2016-08-23
Brief Title:
A Study to Assess the Effect of AZD5634 on Mucociliary Clearance Safety Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 1b Randomized Blinded Placebo-Controlled Cross-Over Study to Assess the Effect of AZD5634 on Mucociliary Clearance as Well as Safety Tolerability and Pharmacokinetic Parameters Following Single Inhaled Dose Administration to Patients With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2018-07
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:
This study will assess the effect of inhaled AZD5634 on Mucociliary clearance MCC in patients with Cystic fibrosis CF after single-dose administration
Detailed Description:
The primary pharmacodynamic endpoint will be the average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles colloids at Visits 2 and 3 MCC 0-60 whole
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