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Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome

NCT ID: NCT02365506

Last Updated: 2020-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-20

Study Completion Date

2016-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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LQT2 Syndrome

Keywords

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Congenital Long QT Syndrome LQTS Sudden Cardiac Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eleclazine 24 mg + Eleclazine 48 mg + Placebo

Participants will receive placebo to match eleclazine on Days 1 and 4, eleclazine 24 mg on Day 2 and eleclazine 48 mg on Day 3.

Group Type EXPERIMENTAL

Eleclazine

Intervention Type DRUG

Tablets administered orally in a single dose

Placebo

Intervention Type DRUG

Placebo to match tablets administered orally in a single dose

Eleclazine 48 mg + Placebo

Participants will receive placebo to match eleclazine on Days 1, 2 and 4, and eleclazine 48 mg on Day 3.

Group Type EXPERIMENTAL

Eleclazine

Intervention Type DRUG

Tablets administered orally in a single dose

Placebo

Intervention Type DRUG

Placebo to match tablets administered orally in a single dose

Placebo

Participants will receive placebo to match eleclazine on Days 1 to 4.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match tablets administered orally in a single dose

Interventions

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Eleclazine

Tablets administered orally in a single dose

Intervention Type DRUG

Placebo

Placebo to match tablets administered orally in a single dose

Intervention Type DRUG

Other Intervention Names

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GS-6615

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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University of Rochester Medical Center/Strong Memorial Hospital

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GS-US-394-1658

Identifier Type: -

Identifier Source: org_study_id