LQT2 Syndrome
Conditions
Keywords
Congenital Long QT Syndrome, LQTS, Sudden Cardiac Death
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.
Interventions
DRUGEleclazine
Tablets administered orally in a single dose
DRUGPlacebo
Placebo to match tablets administered orally in a single dose
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Day 1), Day 3 | Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula. |
| Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Baseline (Day 1), Day 3 | Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e.,T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula. |
| Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Baseline (Day 1), Day 3 | Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Predose, Days 2 and 3 | Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value. |
| Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Baseline (Day 1), Day 3 | Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula. |
| Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Predose, Days 2 and 3 | Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value. |
| Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Baseline (Day 1), Day 3 | Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula. |
| Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Predose, Days 2 and 3 | Maximal reduction from predose (0 hour) is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 1 study site in the United States. The first participant was screened on 20 July 2015. The last study visit occurred on 13 June 2016.
Pre-assignment details
15 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo Participants received single oral dose of placebo to match eleclazine tablet on Days 1 and 4, a single oral dose of eleclazine 24 mg (4 x 6 mg) tablets on Day 2 and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3. | 4 |
| Eleclazine 48 mg + Placebo Participants received single oral dose of placebo to match eleclazine tablet on Days 1, 2 and 4, and a single oral dose of eleclazine 48 mg (8 x 6 mg) tablets on Day 3. | 4 |
| Placebo Participants received placebo to match eleclazine tablets on Days 1 to 4. | 5 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Investigator's Discretion | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Eleclazine 48 mg + Placebo | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 15.3 | 40 years STANDARD_DEVIATION 13.9 | 48 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 1 / 4 | 2 / 4 | 4 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 5 |
Outcome results
Primary
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Time frame: Baseline (Day 1), Day 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Baseline | 453.3 msec | Standard Deviation 8.11 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Change at Day 3 | -7.8 msec | Standard Deviation 7.55 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Baseline | 471.2 msec | Standard Deviation 41.88 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Change at Day 3 | 0.5 msec | Standard Deviation 9.68 |
| Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Baseline | 477.9 msec | Standard Deviation 32.8 |
| Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Global Lead | Change at Day 3 | -3.5 msec | Standard Deviation 3.9 |
p-value: 0.17495% CI: [-16.5, 3.5]Mixed Models Analysis
p-value: 0.44895% CI: [-6.3, 13.1]Mixed Models Analysis
Primary
Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e.,T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Time frame: Baseline (Day 1), Day 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Baseline | 447.7 msec | Standard Deviation 5.48 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Change at Day 3 | -3.4 msec | Standard Deviation 7.72 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Baseline | 464.7 msec | Standard Deviation 34 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Change at Day 3 | 8.7 msec | Standard Deviation 8.96 |
| Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Baseline | 461.2 msec | Standard Deviation 20.01 |
| Placebo | Change From Baseline in Standard 12-Lead ECG Daytime QTcF (AUC0-8)/8 at Day 3: Lead II | Change at Day 3 | 3.3 msec | Standard Deviation 7.19 |
p-value: 0.33895% CI: [-19.8, 7.8]Mixed Models Analysis
p-value: 0.42595% CI: [-9.4, 19.9]Mixed Models Analysis
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
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Time frame: Baseline (Day 1), Day 3
Population: Participants in the Full Analysis Set (included all participants who took at least 1 dose of study drug and had standard 12-lead Day 3 QT measurements recorded) with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | 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 | Baseline | 447.2 msec | Standard Deviation 5.32 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | 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 | Change at Day 3 | -5.3 msec | Standard Deviation 8.31 |
| Eleclazine 48 mg + Placebo | 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 | Baseline | 468.3 msec | Standard Deviation 26.2 |
| Eleclazine 48 mg + Placebo | 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 | Change at Day 3 | 0.4 msec | Standard Deviation 15.2 |
| Placebo | 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 | Baseline | 464.3 msec | Standard Deviation 20.5 |
| Placebo | 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 | Change at Day 3 | 2.1 msec | Standard Deviation 7.71 |
p-value: 0.35895% CI: [-26, 10.5]Mixed Models Analysis
p-value: 0.8495% CI: [-20, 16.7]Mixed Models Analysis
Secondary
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead
Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula.
Time frame: Baseline (Day 1), Day 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Baseline | 461.6 msec | Standard Deviation 7.85 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Change at Day 3 | 3.2 msec | Standard Deviation 8.02 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Baseline | 483.3 msec | Standard Deviation 33.11 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Change at Day 3 | 2.0 msec | Standard Deviation 3.81 |
| Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Baseline | 486.4 msec | Standard Deviation 28.03 |
| Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Global Lead | Change at Day 3 | -0.6 msec | Standard Deviation 14.67 |
p-value: 0.56495% CI: [-14.1, 23.9]Mixed Models Analysis
p-value: 0.72195% CI: [-14.7, 20.2]Mixed Models Analysis
Secondary
Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5
Daily Holter QTcF interval was calculated as the average of the daytime QTcF interval (AUC0-6)/6 and nocturnal QTcF interval (AUC0-6)/6. Daytime AUC0-6 was defined as the area under the QTc curve during the 6 hours postdose and nocturnal AUC0-6 was defined as the area under the QTc curve from midnight to 6am. (AUC0-6)/6 was computed by dividing AUC0-6 by the time difference over the 6 hours. QTcF is corrected QT interval using Fridericia's formula.
Time frame: Baseline (Day 1), Day 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Baseline | 461.6 msec | Standard Deviation 6.89 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Change at Day 3 | 3.5 msec | Standard Deviation 10.37 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Baseline | 466.6 msec | Standard Deviation 20 |
| Eleclazine 48 mg + Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Change at Day 3 | 7.8 msec | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Baseline | 481.2 msec | Standard Deviation 28.12 |
| Placebo | Change From Baseline in Holter Daily QTcF Interval (Daytime and Nocturnal) at Day 3 : Lead V5 | Change at Day 3 | -4.1 msec | Standard Deviation 13.77 |
p-value: 0.33995% CI: [-12, 29.6]Mixed Models Analysis
p-value: 0.17895% CI: [-7.7, 33.4]Mixed Models Analysis
Secondary
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead
Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Time frame: Predose, Days 2 and 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 3 | -23.3 msec | Standard Deviation 6.1 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 2 | -18.3 msec | Standard Deviation 8.31 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Predose | 458.8 msec | Standard Deviation 14.6 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 3 | -15.7 msec | Standard Deviation 14.01 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Predose | 473.5 msec | Standard Deviation 42.27 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 2 | -13.5 msec | Standard Deviation 6.92 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 3 | 2.1 msec | Standard Deviation 11.29 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Day 2 | -4.6 msec | Standard Deviation 17.12 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Global Lead | Predose | 461.7 msec | Standard Deviation 24.49 |
Secondary
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II
Maximal reduction from predose is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Time frame: Predose, Days 2 and 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 2 | -16.5 msec | Standard Deviation 9.34 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Predose | 458.3 msec | Standard Deviation 11.54 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 3 | -21.5 msec | Standard Deviation 6.14 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 2 | -37.1 msec | Standard Deviation 37.79 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Predose | 482.1 msec | Standard Deviation 37.67 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 3 | -35.8 msec | Standard Deviation 24.15 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Predose | 455.8 msec | Standard Deviation 21.61 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 3 | -1.7 msec | Standard Deviation 18.06 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead II | Day 2 | -9.1 msec | Standard Deviation 18.4 |
Secondary
Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5
Maximal reduction from predose (0 hour) is the maximum decrease from predose of the QTc interval (QTcF) at any time point from 1 to 8 hours postdose for Days 2 and 3. QTcF is corrected QT interval using Fridericia's formula. Predose was defined as the Day 2 predose value.
Time frame: Predose, Days 2 and 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 2 | -14.3 msec | Standard Deviation 7.82 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Predose | 450.6 msec | Standard Deviation 13 |
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 3 | -16.3 msec | Standard Deviation 5.8 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 2 | -40.3 msec | Standard Deviation 20.85 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Predose | 481.6 msec | Standard Deviation 33.28 |
| Eleclazine 48 mg + Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 3 | -64.4 msec | Standard Deviation 75.73 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Predose | 453.9 msec | Standard Deviation 20.31 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 3 | 2.8 msec | Standard Deviation 15.57 |
| Placebo | Maximum Reduction From Predose in Standard 12-Lead QTcF on Days 2 and 3: Lead V5 | Day 2 | -9.4 msec | Standard Deviation 14.11 |