Phase 1
N=13
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
LQT2 Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02365506 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: 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 — 447.2; 468.3; 464.3; -5.3 msec — p=0.358
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Eleclazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
447.2; 468.3; 464.3; -5.3; 0.4; 2.1 | 0.358 |
| PRIMARY Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II |
447.7; 464.7; 461.2; -3.4; 8.7; 3.3 | 0.338 |
| PRIMARY Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead |
453.3; 471.2; 477.9; -7.8; 0.5; -3.5 | 0.174 |
| SECONDARY Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 |
461.6; 466.6; 481.2; 3.5; 7.8; -4.1 | 0.339 |
| SECONDARY Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead |
461.6; 483.3; 486.4; 3.2; 2.0; -0.6 | 0.564 |
| SECONDARY Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 |
450.6; 481.6; 453.9; -14.3; -40.3; -9.4 | — |
| SECONDARY Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II |
458.3; 482.1; 455.8; -16.5; -37.1; -9.1 | — |
| SECONDARY Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead |
458.8; 473.5; 461.7; -18.3; -13.5; -4.6 | — |
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.
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT02365506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.