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:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT04688632
Brief Summary:
A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects.
Detailed Description:
A single-center, randomized, double-blind, placebo controlled, positive controlled, multiple dose, parallel group study will be conducted in healthy male and female subjects. Subjects will be randomized to one of 3 groups:
Subjects in Group 1a (n=18) will be administered moxifloxacin placebo on Day 1, ampreloxetine placebo from Day 1 to Day 15, and moxifloxacin \<Dose A\> on Day 15.
Subjects in Group 1b (n=18) will be administered a single oral dose of moxifloxacin \<Dose A\> on Day 1, ampreloxetine placebo from Day 1 to Day 15 and moxifloxacin placebo on Day 15.
Subjects in Group 2 (n=36) will be administered moxifloxacin placebo on Day 1 and on Day 15, and ampreloxetine \<Dose A\> from Day 1 to Day 7, ampreloxetine \<Dose B\> from Day 8 to Day 14, and ampreloxetine placebo on Day 15.
Study:
NCT04688632
Study Brief:
Protocol Section:
NCT04688632