Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 10:26 AM
Study NCT ID:
NCT04688632
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2020-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects
Sponsor:
Theravance Biopharma
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-04
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:
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.
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 Oversight
Has Oversight DMC:
False
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?: