Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eleclazine · 4 trials · 3 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.
| 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). |
| 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 |
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, specifically ventricular arrhythmia, LQT2 syndrome, and long QT syndrome. It is being studied in patients with implantable cardioverter defibrillators or cardiac resynchronization therapy-defibrillators, as well as in participants with LQT2 syndrome.
Eleclazine is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the drug's safety and efficacy in cardiovascular indications.
Eleclazine is in Phase 1 clinical development. While one trial listed as Phase 2 has been completed, the most advanced ongoing development stage is Phase 1. Eleclazine is investigational and has not been approved by regulatory authorities.
Eleclazine has been studied in four completed clinical trials. These include NCT02104583, a Phase 2 trial in ventricular arrhythmia with 313 participants; NCT02365506, a Phase 1 trial in LQT2 syndrome with 13 participants; and two Phase 1 pharmacokinetic trials, NCT02412098 and NCT02441829, in long QT syndrome with 49 and 55 participants respectively.
Eleclazine is also known as GS-6615, its developmental code name. Both names refer to the same investigational drug being developed by Gilead Sciences for the treatment of ventricular arrhythmia and long QT syndrome.