Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867980
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-28
Brief Title:
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
Sponsor:
Acerta Pharma BV
Organization:
Acerta Pharma BV
Study Overview
Official Title:
Randomized Double-Blind Double-Dummy Placebo- and Positive Controlled 4-Way Crossover Study to Assess the Effect of Single-Dose ACP-196 on the QTc Interval in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2021-04
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:
This study is to evaluate the effects of single therapeutic and supratherapeutic oral doses of ACP-196 on the heart rate-corrected QT interval using Fridericias formula QTcF
Detailed Description:
This is a single-dose randomized double-blind double-dummy placebo- and positive-controlled 4-period balanced crossover study under fasting conditions Participants will be randomized to 1 of 4 treatment sequences ABCD BDAC CADB or DCBA On 4 different occasions 4 periods each participant will receive Treatment A a single therapeutic oral dose of 100 mg ACP-196 Treatment B a single supratherapeutic oral dose of 400 mg ACP-196 Treatment C a single oral dose of 400 mg moxifloxacin or Treatment D a single oral dose of ACP-196 and moxifloxacin matching placebos according to a randomization scheme The washout period will be 5 days between each dose The clinic attempted to contact participants using their standard procedures approximately 14 days after the last study drug or placebo administration to determine if any adverse events AEs had occurred since the last dose of study drugs An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship
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