Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-6615
Eleclazine · 7 trials · 4 indications
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.
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.
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.
This endpoint will measure the plasma PK profiles of eleclazine and GS-623134. PK parameters that will be measured include AUC\_0-inf and Cmax.
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Cmax was defined as the maximum observed concentration of drug in plasma.
Cmax was defined as the maximum observed concentration of drug in plasma.
This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC\_0-24, and AUC\_0-tlast.
The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc \[Fridericia\] interval).
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.
Changes in QTc intervals (Fridericia formula; QTcF) from the time-matched ECG in the primary lead V5. In case QT cannot be measured in lead V5, lead II will be designated as the primary lead * Change from the time-matched ECG on Day -1 to Day 1 for Cohorts 1-4 * Change from the time-matched ECG average of Day -1 and Day -2 to Days 1-7 for Cohort 5 and 6
| Arm | Type | Description |
|---|---|---|
| Eleclazine 3 mg | EXPERIMENTAL | Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months. |
| Eleclazine 6 mg | EXPERIMENTAL | Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months. |
| 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. |
| Mild Renal Impairment (CLcr 60-89 mL/min) | EXPERIMENTAL | Participants with mild renal impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Moderate Renal Impairment (CLcr 30-59 mL/min) | EXPERIMENTAL | Participants with moderate impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Severe Renal Impairment (CLcr 15-29 mL/min) | EXPERIMENTAL | Participants with severe renal impairment and matched control participants with normal renal function will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Moderate Hepatic Impairment (Cohort 1) | EXPERIMENTAL | Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Severe Hepatic Impairment (Cohort 2) | EXPERIMENTAL | Participants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Mild Hepatic Impairment (Cohort 3) | EXPERIMENTAL | Participants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). |
| Placebo to match GS-6615 | PLACEBO_COMPARATOR | Placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily |
| GS-6615 | EXPERIMENTAL | GS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily |
| Cohort 1 | EXPERIMENTAL | Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo |
| Cohort 2 | EXPERIMENTAL | Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo |
| Cohort 3 | EXPERIMENTAL | Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo |
| Cohort 4 | EXPERIMENTAL | Participants will receive a single 60 mg dose of GS-6615. |
| Cohort 5 | EXPERIMENTAL | Participants will receive single doses of GS-6615 as follows: * Day 1: 20 mg (loading dose) * Day 2: 40 mg (loading dose) * Days 3-7: 6 mg (maintenance dose) once daily If a participant has a QTcF value of ≤ 420 msec on 2 consecutive time points after the 20 mg dose on Day 1, the participant will receive the maintenance dose of 6 mg on Day 2. |
| Cohort 6 | EXPERIMENTAL | Participants will receive single doses of GS-6615 as follows: * Day 1: 50 mg (loading dose) * Day 2-3: 10 mg once daily * Days 4-7: 20 mg once daily |
| Name | Type | Description |
|---|---|---|
| Eleclazine | DRUG | Eleclazine tablets administered orally |
| Placebo to match eleclazine | DRUG | Placebo to match eleclazine tablets administered orally |
| Placebo | DRUG | Placebo to match tablets administered orally in a single dose |
| GS-6615 | DRUG | GS-6615 tablets administered orally |
| Placebo to match GS-6615 | DRUG | Placebo to match GS-6615 tablets administered orally |
| Placebo to match dofetilide | DRUG | Placebo to match dofetilide capsules administered orally |
| Dofetilide | DRUG | Dofetilide 500 μg capsules administered orally according to the current prescribing information |
Key Inclusion Criteria: * Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) \[shock or ATP\] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within...
Eleclazine is an investigational small molecule being developed for cardiovascular conditions including LQT2 Syndrome, Long QT Syndrome, and Ventricular Arrhythmia. It is not approved and remains in clinical development.
Eleclazine is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD.
Eleclazine is in Phase 1 clinical development. It has completed Phase 1 and Phase 2 trials, but it is not FDA approved and remains investigational.
Eleclazine has been studied in four completed trials: NCT02104583 (Phase 2, ventricular arrhythmia), NCT02365506 (Phase 1, LQT2 syndrome), NCT02412098 (Phase 1, hepatic impairment), and NCT02441829 (Phase 1, renal impairment).
Eleclazine is also known as GS-6615. Both names refer to the same investigational drug developed by Gilead Sciences for cardiac arrhythmias.