CompletedPhase 1

Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects

United States72 participantsStarted 2021-01-18

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Subject is willing and able to give written informed consent.
✓. Subject is a healthy, nonsmoking man or woman, 18 to 55 years of age, at screening.
✓. Subject must be willing to abide by the following pregnancy precautions:
✓. Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive, and weight of at least 55 kg at screening.
✓. Subject has normal blood pressure (BP) and HR, measured after resting seated or supine for approximately 5 minutes. Normal BP is defined as 90 to 140 mmHg systolic and 50 to 90 mmHg diastolic. Normal HR is defined as 45 to 99 beats per minute (bpm) at screening and Day -2.
✓. Subject is able to communicate well with the investigator and to comply with the study procedures, requirements, and restrictions.

Exclusion criteria

✕. Subject has any clinically relevant abnormalities, as determined by the investigator, in the laboratory results at screening or Day -2. Except for the following clinical laboratory assessments outside the range specified:
✕. Positive results at screening for human immunodeficiency virus (HIV), hepatitis A virus (HAV) antibodies (anti-HAV: both IgG and IgM positive, IgG positive in the absence of IgM positive is acceptable), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
✕. Within 4 weeks of screening and through Day 1, subject has:
✕. Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) (test RT-PCR positive), OR
✕. Suspected SARS-CoV-2 infection (clinical features without documented test results) unless has a negative RT-PCR test for SARS-CoV-2 at least two weeks after resolution of symptoms and remains asymptomatic until Day 1, OR
✕. Close contact with a person with known or suspected SARS-CoV-2 infection unless has a negative RT-PCR test for SARS-CoV-2 at least two weeks after contact and remains asymptomatic until Day 1.
✕. Subject has a prior history of myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, ventricular tachycardia, atrial fibrillation, personal or known family history of congenital long QT syndrome or known family history of sudden death with unknown cause prior to the age of 50, a pacemaker or implantable cardioverter defibrillator, cardiac or cerebral stent placement or angioplasty, or clinically significant valvular heart disease.
✕. Subject has a history of orthostatic hypotension or orthostatic tachycardia or a history of dizziness, lightheadedness or fainting, or a feeling of blacking out upon standing, secondary to autonomic failure or other chronic cardiovascular condition.

What they're measuring

QTcF

Timeframe: Days -1, 1, 7, 8, 14 and 15

Trial details

NCT IDNCT04688632

SponsorTheravance Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-13

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