Approval Probability
TA Base Rate
Adjusted LOA
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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 drug being developed by GSK plc for the treatment of type 2 diabetes mellitus. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in healthy male volunteers. SRT3025 has not been approved by the FDA.
SRT3025 is being developed for the treatment of type 2 diabetes mellitus, a metabolic disease. It is an investigational therapy and is not approved for any indication. The only reported clinical trial of SRT3025 enrolled healthy male volunteers to investigate different doses of the drug for metabolic diseases.
SRT3025 is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program for SRT3025 in type 2 diabetes mellitus.
SRT3025 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials. The completed study was a randomized, active-controlled Phase 1 trial in healthy male volunteers. SRT3025 is investigational and has not been approved by the FDA.
SRT3025 has been studied in one completed Phase 1 clinical trial, NCT01340911, titled "A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases." The trial enrolled 78 healthy male volunteers in the United Kingdom and was randomized and active-controlled.