Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-6615 · 3 trials · 2 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
| Placebo | DRUG | Placebo tablet(s) to match GS-6615 administered orally once daily |
Inclusion Criteria: * Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs * Have a calculated body mass index (BMI) from 18 to 30 kg/m\^2, inclusive, at study screening * Have either a normal 12-lead electrocardiogra...
GS-6615 is an investigational small molecule being developed for Long QT Syndrome and Ischemic Heart Disease. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its effects on cardiac conditions, specifically in patients with LQT-3 and healthy subjects.
GS-6615 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting Phase 1 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of GS-6615.
GS-6615 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All clinical trials for GS-6615 have been completed, with no active trials currently ongoing.
GS-6615 has been studied in three completed Phase 1 clinical trials: NCT01847391, NCT01849003, and NCT02365532. These trials assessed the safety, tolerability, pharmacokinetics, and effects on QT prolongation in healthy subjects and patients with Long QT Syndrome.
GS-6615 is also known as eleclazine, a late sodium current inhibitor being studied for cardiac conditions. In clinical trials, it has been evaluated for its effects on Long QT Syndrome and Ischemic Heart Disease.