| Trial ID: | L6860 |
| Source ID: | NCT01340911
|
| Associated Drug: |
Srt3025
|
| Title: |
A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: SRT3025|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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., 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., 21 days | Secondary: 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., 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., 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., 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., 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., 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., 21 days
|
| Sponsor/Collaborators: |
Sponsor: Sirtris, a GSK Company
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2011-06-03
|
| Completion Date: |
2011-11-24
|
| Results First Posted: |
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| Last Update Posted: |
2017-10-30
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| Locations: |
GSK Investigational Site, Harrow, Middlesex, HA1 3UJ, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT01340911
|
