A Phase 1 interventional study of SRT3025 and Placebo in Diabetes Mellitus, Type 2, sponsored by Sirtris, a GSK Company. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-30.
Sponsored by Sirtris, a GSK Company · Phase 1, Interventional, and Basic science
The main purpose of the study is to see how safe SRT3025 (study drug) is when given at different doses. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how taking the study drug after eating might change this process.
SRT3025 is being developed for the treatment of metabolic diseases. This study is the first administration of SRT3025 in humans and seeks to establish the initial safety, tolerability, and pharmacokinetic (PK) profile of SRT3025 (and any metabolites, if analyzed) before proceeding to future Phase 1 studies or Phase 2 patient studies.
This protocol details a Phase 1, randomized, placebo-controlled, single-blind, dose escalation study to determine the safety, tolerability, and PK profile of SRT3025 in healthy male subjects. The study will be conducted in two parts. In Part 1A, 6 Cohorts of subjects will receive single escalating doses of SRT3025. In Part 1B, an additional one to two cohorts may be enrolled to investigate the effect of a moderate fat/calorie meal on single dose PK endpoints. In Part 2A, up to three cohorts may be enrolled to receive 14-day repeat doses of SRT3025 chosen from the Part 1A safety, tolerability, and PK data. In Part 2B, one to two additional cohorts may receive 14-day repeat doses of SRT3025 in combination with a moderate fat/calorie meal.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 78 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sirtris, a GSK Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: SRT3025 · Drug: Placebo
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.
Drug: SRT3025
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.
Drug: SRT3025 · Drug: Placebo
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.
Drug: SRT3025
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.
For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of a single dose of SRT3025 in healthy male subjects.
Time frame: 9 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple doses of SRT3025 in healthy male subjects.
Time frame: 21 days
Plasma levels of SRT3025 will be measured in all subjects that received a single dose of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Plasma levels of SRT3025 will be measured in all subjects that received a single dose of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Time frame: 24 hours
Plasma levels of SRT3025 will be measured in all subjects that received multiple doses of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Plasma levels of SRT3025 will be measured in all subjects that received multiple doses of the study drug at fasted and fed states to assess the pharmacokinetics and bioavailability of SRT3025.
Time frame: 14 days
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received a single dose of SRT3025.
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received a single dose of SRT3025.
Time frame: 24 hours
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received multiple dose of SRT3025.
SRT3025 metabolite levels in urine and plasma will be measured in all subjects that received multiple dose of SRT3025.
Time frame: 15 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving a single dose of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving a single dose of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Time frame: 9 days
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving multiple doses of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Plasma levels of SRT3025 may be compared to the number and types of adverse events experienced by subjects receiving multiple doses of SRT3025 to assess any relationship between plasma SRT3025 levels and adverse events.
Time frame: 21 days
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Sirtris, a GSK Company