Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194032
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-12-21
Brief Title:
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo Using Moxifloxacin as a Positive Control in Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Single-centre Randomised Double-blind Placebo-controlled Four-Way Crossover Phase I Thorough QTc Study to Investigate the Effect on QTcF of Single Doses of Baxdrostat Compared With Placebo Using Open-label Moxifloxacin as a Positive Control in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-05
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 single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave QT interval corrected for HR using Fridericias formula QTcF compared to placebo using a concentration-QTcF analysis and with moxifloxacin as positive control in healthy participants
Detailed Description:
This is a randomised placebo-controlled double-blind 4-way crossover TQT study to assess the effect of single oral doses of baxdrostat on the QTcF compared to placebo using a concentration-QTcF analysis and with open-label moxifloxacin as positive control in 28 healthy participants performed at a single clinical unit
The study will comprise of
a screening period of maximum 28 days
four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing Treatment Period Day 3
a final Follow-up Visit within 7 to 10 days following discharge after Visit 5
Participants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4
Treatment Periods will be separated by a washout period of at least 7 days but no more than 9 days
The study will comprise of
a screening period of maximum 28 days
four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing Treatment Period Day 3
a final Follow-up Visit within 7 to 10 days following discharge after Visit 5
Participants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4
Treatment Periods will be separated by a washout period of at least 7 days but no more than 9 days
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?:
True
Is an FDA AA801 Violation?:
None