CompletedPhase 1

Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers

United States32 participantsStarted 2019-05-23

Plain-language summary

This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc).

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Normal sinus rhythm (heart rate between 45 beats per minute \[bpm\] and 100 bpm inclusive);
✓. Fridericia-corrected QTc (QTcF) interval \< 450 milliseconds (msec);
✓. QRS interval ≤ 110 msec; and confirmed by manual over read if \> 110 msec;
✓. PR interval ≤ 220 msec;
✓. No electrographically significant abnormalities that might interfere with ECG analysis including evidence of a previous myocardial infarction (MI), significant left ventricular hypertrophy (LVH), flat T-waves (particularly in the inferior leads) or more than minor non-specific ST-T wave changes

Exclusion criteria

✕. Any drug, including prescription and non-prescription medications (including antacids), herbal remedies, or vitamin supplements (especially those containing magnesium, aluminum, iron, or zinc) beginning 14 days prior to the first dose of study drug and throughout the study. Co-administration of ETX2514 and probenecid is prohibited.
✕. Any drugs known to be significant inhibitors or inducers of cytochrome P450 (CYP) enzymes and/or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study.
✕. hypokalemia, in the opinion of the PI;
✕. risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome);
✕. sick sinus syndrome, second- or third-degree atrioventricular block, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities;
✕. repeated or frequent vasovagal episodes:

What they're measuring

Placebo-corrected change from Baseline in Fridericia-corrected QTc (QTcF) (ΔΔQTcF)

Timeframe: Baseline; up to Day 22

Trial details

NCT IDNCT03985410

SponsorEntasis Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-24

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