Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRT3025 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1A, Cohorts 1-6 | ACTIVE_COMPARATOR | Approximately 48 healthy male subjects will be enrolled into 6 separate cohorts (8 subjects per cohort). Each Cohort of subjects will be dosed sequentially, approximately one week apart, at escalating doses. Within each cohort, 6 subjects will be randomized to receive a single dose of SRT3025, and 2 will be randomized to receive a single dose of placebo. The following are the planned doses for Cohorts 1-6, with Cohort 1 being the lowest dose and Cohort 6 being the highest dose: 50, 150, 500, 1000, 2000, and 3000mg of SRT3025. Dose level may be altered as appropriate during the study based on real time analysis of the safety, tolerability, and /or PK data. Dose adjustment may involve an increase or decrease in dose or dividing the total daily dose allowing for twice-daily dosing. Total daily dosing will not exceed 3000mg. |
| Part 1B, Cohorts 7-8 | ACTIVE_COMPARATOR | One to two of the doses administered in Part 1A may be selected for administration with food, based on expected changes in SRT3025 exposures with food, as well as safety, tolerability, and PK data from Part 1A. If initiated, the effect of a single dose of SRT3025 with a moderate fat/calorie meal may be initiated concurrently with a cohort in Part 2 of the study. Approximately 6 subjects would be enrolled into each cohort in Part 1B. |
| Part 2A, Cohorts 9-11 | ACTIVE_COMPARATOR | Approximately 16-24 healthy subjects will be enrolled into 2 to 3 cohorts (8 subjects per cohort) in Part 2A. Within each cohort, 6 subjects will be randomized to receive multiple doses of SRT3025, and 2 will be randomized to receive multiple doses of placebo. The repeat dosing component of the study will be initiated, and doses selected, based on the evaluation of safety, tolerability, and PK data from Part 1A. Subjects in Part 2A will be randomized to receive 14 consecutive days of dosing with SRT3025 or matched-placebo. Subjects in these Cohorts will be dosed sequentially (in the fasted state) approximately two weeks apart. |
| Part 2B, Cohorts 12-13 | ACTIVE_COMPARATOR | If initiated, the effect of repeat doses of SRT3025 with moderate fat/calorie meals would occur in Part 2B (Cohorts 12 and 13). Each of these cohorts would enroll approximately 6 subjects. |
| Name | Type | Description |
|---|---|---|
| SRT3025 | DRUG | SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance. |
| Placebo | DRUG | For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...
SRT3025 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.
SRT3025 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical research on this drug for metabolic diseases.
SRT3025 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled study in healthy male volunteers. The drug is investigational and has not been approved for any use.
SRT3025 has been studied in one completed Phase 1 clinical trial, identified as NCT01340911. This trial investigated different doses of the drug in healthy male volunteers for the treatment of metabolic diseases, including Type 2 Diabetes Mellitus, and enrolled 78 participants in the United Kingdom.
SRT3025 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.