NCT04688632

Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Symptomatic Neurogenic Orthostatic Hypertension
• nOH

Interventions

Type	Name	Description
DRUG	Ampreloxetine <Dose A>	Ampreloxetine \<Dose A\> will be administered as 1 tablet of \<Dose A\> and 3 tablets of Ampreloxetine Placebo.
DRUG	Ampreloxetine <Dose B>	Ampreloxetine \<Dose B\> will be administered as 4 tablets of \<Dose A\>
DRUG	Ampreloxetine Placebo	Ampreloxetine Placebo will be administered as 4 tablets of placebo. The placebo tablet will match (in appearance) the ampreloxetine \<Dose A\> tablet.
DRUG	Moxifloxacin	Moxifloxacin will be administered orally as a single tablet.
DRUG	Moxifloxacin Placebo	Moxifloxacin placebo will be administered orally as a single tablet. The placebo tablet will match (in appearance) the moxifloxacin tablet.

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-03-13
• Completion: 2021-03-26
• First posted: 2020-12-30
• Last updated: 2021-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study