Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02365532 | Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults | PHASE1 | COMPLETED | 60 | — | — | Feb 1, 2015 | May 1, 2015 | May 20, 2015 | 1 | United States |
| NCT01849003 | Study of the Effect of GS-6615 in Subjects With LQT-3 | PHASE1 | COMPLETED | 24 | — | — | May 1, 2013 | Nov 1, 2014 | Nov 17, 2014 | 1 | United States |
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.
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 | Participants will receive a single 10 mg dose of GS-6615. |
| Cohort 2 | EXPERIMENTAL | Participants will receive a single 20 mg dose of GS-6615. |
| Cohort 3 | EXPERIMENTAL | Participants will receive a single 30 mg dose of GS-6615. |
| 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 |
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...