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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eleclazine 24 mg + Eleclazine 48 mg + Placebo | Experimental | 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. |
|
| Eleclazine 48 mg + Placebo | Experimental | Participants will receive placebo to match eleclazine on Days 1, 2 and 4, and eleclazine 48 mg on Day 3. |
|
| Placebo | Placebo Comparator | Participants will receive placebo to match eleclazine on Days 1 to 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleclazine | Drug | Tablets administered orally in a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), Day 3 |
| 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. | Baseline (Day 1), Day 3 |
| 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. | Baseline (Day 1), Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center/Strong Memorial Hospital | Rochester | New York | 14620 | United States |
15 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Placebo | Participants received placebo to match eleclazine tablets on Days 1 to 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1), Day 3 |
|
First dose date up to 30 days after last dose of study drug (up to Day 34)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| ID | Term |
|---|---|
| C563614 | Long Qt Syndrome 2 |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| C000624281 | eleclazine |
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| Placebo | Drug | Placebo to match tablets administered orally in a single dose |
|
| Baseline (Day 1), Day 3 |
| 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. | Baseline (Day 1), Day 3 |
| 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. | Predose, Days 2 and 3 |
| 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. | Predose, Days 2 and 3 |
| 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. | Predose, Days 2 and 3 |
| 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. |
| BG002 | Placebo | Participants received placebo to match eleclazine tablets on Days 1 to 4. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | 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. |
| OG002 | Placebo | Participants received placebo to match eleclazine tablets on Days 1 to 4. |
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1), Day 3 |
|
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1), Day 3 |
|
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1), Day 3 |
|
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1), Day 3 |
|
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Predose, Days 2 and 3 |
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Predose, Days 2 and 3 |
|
|
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | msec | Predose, Days 2 and 3 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Placebo | Participants received placebo to match eleclazine tablets on Days 1 to 4. | 0 | 5 | 0 | 5 | 4 | 5 |
| Pericarditis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
| Mixed Models Analysis |
p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| 0.425 |
| Difference in LSM |
| 5.3 |
| Standard Error of the Mean |
| 6.21 |
| 2-Sided |
| 95 |
| -9.4 |
| 19.9 |
LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| Superiority |
|
|
| Mixed Models Analysis |
p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| 0.448 |
| Difference in LSM |
| 3.4 |
| Standard Error of the Mean |
| 4.28 |
| 2-Sided |
| 95 |
| -6.3 |
| 13.1 |
LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| Superiority |
|
|
| Mixed Models Analysis |
p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| 0.178 |
| Difference in LSM |
| 12.8 |
| Standard Error of the Mean |
| 8.40 |
| 2-Sided |
| 95 |
| -7.7 |
| 33.4 |
LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| Superiority |
|
| 0.721 |
| Difference in LSM |
| 2.7 |
| Standard Error of the Mean |
| 7.38 |
| 2-Sided |
| 95 |
| -14.7 |
| 20.2 |
LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate. |
| Superiority |
|
| Day 3 |
|
|
| Day 3 |
|
|
| Day 3 |
|