MedTrace Logo

Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects

NCT04688632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-04-20

No results posted yet for this study

Summary

A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects.

Conditions

  • Symptomatic Neurogenic Orthostatic Hypertension
  • nOH

Interventions

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.

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-03-13
Completion
2021-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688632 on ClinicalTrials.gov