Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRT2379 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 50mg SRT2379 | ACTIVE_COMPARATOR | Single oral administration of 50mg SRT2379 |
| 250mg SRT2379 | ACTIVE_COMPARATOR | Single oral administration of 250mg SRT2379 |
| 1000mg SRT2379 | ACTIVE_COMPARATOR | Single oral administration of 1000mg SRT2379 |
| Placebo | PLACEBO_COMPARATOR | Single oral administration of placebo |
| 1.0 g SRT2379 | ACTIVE_COMPARATOR | Single dose of 1.0g of SRT2379 |
| 1.0 g Placebo | PLACEBO_COMPARATOR | Single dose of 1.0g of placebo |
| Cohort 1 - Dose Level A (25 mg/day) | ACTIVE_COMPARATOR | Cohort 1 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 25 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 25 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 2 - Dose Level B (75 mg/day) | ACTIVE_COMPARATOR | Cohort 2 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 75 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 75 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 3 - Dose Level C (250 mg/day) | ACTIVE_COMPARATOR | Cohort 3 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 250 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 250 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 4 - Dose Level D (500 mg/day) | ACTIVE_COMPARATOR | Cohort 4 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 500 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 500 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 5 - Dose Level E (1000 mg/day) | ACTIVE_COMPARATOR | Cohort 5 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 1000 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 1000 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 6 - Dose Level F (2000 mg/day) | ACTIVE_COMPARATOR | Cohort 6 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 2000 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 2000 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 7 - Dose Level G (3000 mg/day) | ACTIVE_COMPARATOR | Cohort 7 will be administered at approximately the same time every dosing day after fasting for 10hrs. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving 3000 mg SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving 3000 mg SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The other cohorts will be dosed sequentially allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort. |
| Cohort 8 - Dose Level H (500 mg/day in fed state) | ACTIVE_COMPARATOR | Cohort 8 will be administered at approximately the same time every dosing day and 30 minutes following the start of consumption of a standardized high-fat meal. Two subjects will be dosed on Day 1 of the single dose period with one subject receiving SRT2379 and one subject receiving placebo. The remainder of subjects in this cohort will be dosed on Day 2 of the single dose period with five subjects receiving SRT2379 and one subject receiving placebo, assuming that no significant safety issues arise in the two subjects dosed on Day 1. Subjects will remain on a fixed dose of test material for all dosing days in the study. The dose of SRT2379 administered to subjects in the fed state is planned to be 500 mg, however this may be modified upwards or downwards following evaluation of safety and pharmacokinetic data from earlier cohorts. The fed cohort will be the final cohort dosed in the study. |
| Name | Type | Description |
|---|---|---|
| SRT2379 | DRUG | SRT2379 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt. |
| Placebo | DRUG | For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product. |
Inclusion Criteria: * Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out within 21 days prior to Day 1. A subject with a clinical abnormality or laboratory parameters ...
SRT2379 is an investigational small molecule being studied for Type 2 Diabetes Mellitus and Sepsis. It has been evaluated in Phase 1 clinical trials, including studies in healthy male volunteers to assess safety, pharmacokinetics, and effects on endotoxin-induced inflammation. SRT2379 is not approved and remains in clinical development.
SRT2379 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for Type 2 Diabetes Mellitus and Sepsis.
SRT2379 is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The drug is investigational and has not been approved for any use.
SRT2379 has been studied in three completed Phase 1 trials: NCT01018628, a safety and pharmacokinetics study in healthy male volunteers; NCT01262911, an endotoxin-induced inflammation study; and NCT01416376, a multiple dose level study on endotoxin-induced inflammation. All trials are completed.
No alternative names for SRT2379 have been reported. The drug is identified solely by its code name SRT2379 in clinical trial registrations and is being developed by GSK plc.