Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01031108
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2009-12-10
Brief Title:
A Clinical Trial to Assess the Safety of Oral SRT2104 and Its Effects on Vascular Dysfunction in Otherwise Healthy Cigarette Smokers and Subjects With Type 2 Diabetes Mellitus
Sponsor:
Sirtris a GSK Company
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Randomized Placebo-Controlled Crossover Clinical Trial to Assess the Safety of Oral SRT2104 and Its Effects on Vascular Dysfunction in Otherwise Healthy Cigarette Smokers and Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the safety and tolerability of SRT2104 20 g administered once daily for 28 days and to examine the effects of SRT2104 20 g administered once daily for 28 days on reversing vasomotor and fibrinolytic dysfunction in both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed state
This study will investigate the effects of SRT2104 on the reduction of platelet activation markers platelet-monocyte aggregates and to evaluate the effects of SRT2104 on platelet and monocyte surface markers P-selectin CD11b inflammatory markers high sensitivity CRP IL-6 SAA TNF-α and sCD40L and markers of oxidative stress urinary and plasma F2-isoprostanes and nitrotyrosine
Further goals of this study is to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed state and to explore the effects of SRT2104 on potential biomarkers of activity for glucose control HbA1c glycated albumin and fructosamine andor Sirt1 activation
This study will investigate the effects of SRT2104 on the reduction of platelet activation markers platelet-monocyte aggregates and to evaluate the effects of SRT2104 on platelet and monocyte surface markers P-selectin CD11b inflammatory markers high sensitivity CRP IL-6 SAA TNF-α and sCD40L and markers of oxidative stress urinary and plasma F2-isoprostanes and nitrotyrosine
Further goals of this study is to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed state and to explore the effects of SRT2104 on potential biomarkers of activity for glucose control HbA1c glycated albumin and fructosamine andor Sirt1 activation
Detailed Description:
Single-center randomized double-blind placebo-controlled crossover safety activity and pharmacokinetic PK study of 20 g of SRT2104 administered orally once daily for 28 consecutive days to two different populations type 2 diabetic T2D subjects on an existing stable hypoglycemic regimen and otherwise healthy cigarette smokers 10cigarettesday for at least 1 year Approximately 24 subjects with T2D and 24 otherwise healthy cigarette smokers aged 18-60 years who fulfill the inclusionexclusion criteria will be enrolled in this study to ensure at least 20 evaluable subjects per population are enrolled Subjects will be evenly stratified and randomized to receive SRT2104 20 gday or placebo once daily for 28 days After 28 days subjects will cross over to receive the other test article for another 28 days of dosing bringing the total dosing period to 56 days
Subjects will sign the informed consent form at the screening visit to occur within 21 days of first dose of test article and will undergo screening assessments to verify eligibility for the study If eligible and willing to participate subjects will return to the clinic on Days -1 and 1 for safety assessments hematology and biochemistry measurements platelet monocyte aggregation PMA assessment forearm venous occlusion plethysmography pulse wave analysis PWA pulse wave velocity PWV and PK sampling The first dose of test article will occur on Day 1 after eligibility has been confirmed After each 28 day dosing period subjects will return on Day 28 and Day 56 for safety assessments hematology and biochemistry measurements forearm plethysmography PWA PWV and PK sampling Subjects will return to the clinic on Days 2 15 29 43 and 57 for safety assessments and additional PK sampling Subjects will be asked to complete a study drug diary on a daily basis for compliance and adverse event AE monitoring diabetic subjects will be required to monitor and record their fasting blood glucose in the diary also An End of Study visit will occur 14 days following the final dose of SRT2104 or placebo on Day 70 A followup safety call will be made to each subject 30 days following their final dose of SRT2104 or placebo Day 86
Subjects will sign the informed consent form at the screening visit to occur within 21 days of first dose of test article and will undergo screening assessments to verify eligibility for the study If eligible and willing to participate subjects will return to the clinic on Days -1 and 1 for safety assessments hematology and biochemistry measurements platelet monocyte aggregation PMA assessment forearm venous occlusion plethysmography pulse wave analysis PWA pulse wave velocity PWV and PK sampling The first dose of test article will occur on Day 1 after eligibility has been confirmed After each 28 day dosing period subjects will return on Day 28 and Day 56 for safety assessments hematology and biochemistry measurements forearm plethysmography PWA PWV and PK sampling Subjects will return to the clinic on Days 2 15 29 43 and 57 for safety assessments and additional PK sampling Subjects will be asked to complete a study drug diary on a daily basis for compliance and adverse event AE monitoring diabetic subjects will be required to monitor and record their fasting blood glucose in the diary also An End of Study visit will occur 14 days following the final dose of SRT2104 or placebo on Day 70 A followup safety call will be made to each subject 30 days following their final dose of SRT2104 or placebo Day 86
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None