Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05841160
Brief Summary:
THOROUGH QT/QTc 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 1:1:1:1 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:
NCT05841160
Study Brief:
Protocol Section:
NCT05841160