Clinical trial NCT02365506: Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
Official title: A Double-blind, Placebo-controlled Study to Evaluate the Effect of GS-6615 on QT, Safety and Tolerability in Subjects With Long QT2 Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: LQT2 Syndrome
Keywords: Congenital Long QT Syndrome
LQTS
Sudden Cardiac Death
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) \< 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.

Primary outcomes:
measure: 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
measure: Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II
timeFrame: Baseline (Day 1), Day 3
measure: Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead
timeFrame: Baseline (Day 1), Day 3
Secondary outcomes:
measure: Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5
timeFrame: Baseline (Day 1), Day 3
measure: Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead
timeFrame: Baseline (Day 1), Day 3
measure: Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5
timeFrame: Predose, Days 2 and 3
measure: Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II
timeFrame: Predose, Days 2 and 3
measure: Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead
timeFrame: Predose, Days 2 and 3
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center/Strong Memorial Hospital
state: New York
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: