Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841160
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2023-04-10
Brief Title:
Thorough QTQTc Study to Evaluate the Effects of Ecopipam EBS-101 on Cardiac Repolarization
Sponsor:
Emalex Biosciences Inc
Organization:
Emalex Biosciences Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo- and Positive Controlled Crossover Thorough QTQTc Study to Evaluate the Effects of a Therapeutic and Supratherapeutic Dose of Ecopipam EBS-101 on Cardiac Repolarization in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-06
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:
THOROUGH QTQTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM EBS-101 ON CARDIAC REPOLARIZATION
Detailed Description:
This is a single-center randomized partially double-blind open-label moxifloxacin placebo- and positive-controlled 4-way crossover study in healthy subjects Following a 28 day screening period eligible subjects will enter the clinical research unit CRU on Day -1 A total of 32 subjects will be randomized in a 1111 ratio to 1 of 4 treatment sequences 8 subjects per treatment sequence Subjects will receive the assigned study drug as a single oral dose in the morning on Day 1 of each treatment period Day 1 Period 1 Day 8 Period 2 Day 15 Period 3 and Day 22 Period 4 after an overnight fast Subjects will have serially matched blood samples for determination of plasma concentrations and 12-lead ECGs collected at predose and up to 48 hours after each dose for C QTc analysis Subjects will be discharged from the CRU 96 hours after the last dose of the study drug Day 26 A follow-up telephone call will occur 5 2 days after discharge Day 31 2
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