Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With L… (NCT02365506) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
United States13 participantsStarted 2015-07-20
Plain-language summary
The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Participants with an established diagnosis of LQT2 (by genotype testing)
* Mean (of triplicate) QTc interval ≥ 480 msec for at least four out of seven time points, determined by standard 12-lead electrocardiogram (ECG), at screening
Key Exclusion Criteria:
* Known mutations associated with long QT syndrome type 1 or long QT syndrome type 3
* Known or suspected history of seizures or epilepsy
* History of heart failure defined as New York Heart Association (NYHA) Class IV and/or known left ventricular ejection fraction (EF) ≤ 45%
* Body mass index (BMI) ≥ 36 kg/m\^2 at screening
* Severe renal impairment at screening (defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2, using the 4 variable modification of diet in renal disease (MDRD) equation), as determined by the study center
* Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN
* An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD) implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to screening
* Any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
What they're measuring
1
Change From Baseline in Standard 12-Lead Electrocardiogram (ECG) Daytime QT Interval Corrected For Heart Rate Using The Fridericia Formula (QTcF) (AUC0-8)/8 at Day 3: Lead V5
Timeframe: Baseline (Day 1), Day 3
2
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II
Timeframe: Baseline (Day 1), Day 3
3
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead