nOH Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, Thorough QT Study to Evaluate the Effect of Ampreloxetine on Cardiac Repolarization in Healthy Subjects
A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04200573 -
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
|
Phase 1 |