Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01018628
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2009-11-19
Brief Title:
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Randomized Placebo-Controlled Single-Blind Multiple-Dose Dose-Escalation Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers
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 main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 25 75 250 500 1000 2000 and 3000 mgday fasted and 500 mgday fed in healthy male volunteers
The purpose is also to explore the effect of SRT2379 on plasma concentrations of Fibroblast Growth Factor 21 FGF21 and to identify other possible biomarkers suitable for future clinical assessment of oral SIRT1 activators
The purpose is also to explore the effect of SRT2379 on plasma concentrations of Fibroblast Growth Factor 21 FGF21 and to identify other possible biomarkers suitable for future clinical assessment of oral SIRT1 activators
Detailed Description:
Prospective single center clinical study of SRT2379 administered orally Randomized placebo-controlled single-blind multiple-dose dose-escalation inpatientoutpatient study to assess the safety and pharmacokinetics PK of SRT2379 in healthy male volunteers Approximately sixty-four 64 subjects aged 18-55 who fulfill the inclusionexclusion criteria will be enrolled in this study Eight cohorts of eight subjects each will be examined Subjects within each cohort will be randomized 62 to receive SRT2379 at one of seven escalating doses A B C D E F or G likely to be 25 75 250 500 1000 2000 and 3000 mgday or placebo All cohorts will be administered SRT2379 in the fasted state with the exception of one cohort that will receive one of the stated doses of SRT2379 in the fed state the dose of SRT2379 administered to subjects in the fed state is planned to be 500 mg however this may be modified upwards or downwards following evaluation of safety and pharmacokinetic data from earlier cohorts The fed cohort will be the final cohort dosed in the study Two subjects will be dosed on Day 1 of the single dose period with one subject receiving active treatment and one subject receiving placebo The remainder of subjects within each cohort will be dosed on Day 2 of the single dose period with five subjects receiving active treatment and one subject receiving placebo assuming that no safety issues arise in the two subjects dosed on Day 1 Subjects will remain on a fixed dose of test material for all dosing days in the study
Each cohort of subjects will be dosed sequentially approximately three weeks apart for the single dose period and return to the study unit approximately two weeks after their single dose administration to receive 7 consecutive days of dosing for the multiple-dose period Each cohort of subjects in the multiple-dose period will be dosed sequentially approximately two weeks apart from multiple dose period Day 7 of preceding cohort to multiple dose period Day 1 dose of the subsequent cohort allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort
Subjects will sign the informed consent form at the Screening Visit If eligible and willing to participate subjects will enter into the study Subjects will have fasted for at least 10 hours overnight and be randomized to receive SRT2379 or placebo test material The subject cohort assigned to the fed dose will consume a standardized meal before receiving test material all other subjects will receive test material in a fasted state Subjects will be required to stay overnight at the study unit for two nights during the single dose period of the study and subsequently for the duration of the seven-day multiple-dose period 8 consecutive overnight stays to assess safety and to gather required PK samples Subjects will be asked to return to the study center for an End of Study safety assessment approximately 1 week after the last administration of study drug during the multiple-dose period
Dose escalation will be dependent on safety parameters physical examination findings vital signs ECG studies adverse events and laboratory values and PK data
Each cohort of subjects will be dosed sequentially approximately three weeks apart for the single dose period and return to the study unit approximately two weeks after their single dose administration to receive 7 consecutive days of dosing for the multiple-dose period Each cohort of subjects in the multiple-dose period will be dosed sequentially approximately two weeks apart from multiple dose period Day 7 of preceding cohort to multiple dose period Day 1 dose of the subsequent cohort allowing for a comprehensive safety assessment prior to initiation of an escalated dose in a subsequent cohort
Subjects will sign the informed consent form at the Screening Visit If eligible and willing to participate subjects will enter into the study Subjects will have fasted for at least 10 hours overnight and be randomized to receive SRT2379 or placebo test material The subject cohort assigned to the fed dose will consume a standardized meal before receiving test material all other subjects will receive test material in a fasted state Subjects will be required to stay overnight at the study unit for two nights during the single dose period of the study and subsequently for the duration of the seven-day multiple-dose period 8 consecutive overnight stays to assess safety and to gather required PK samples Subjects will be asked to return to the study center for an End of Study safety assessment approximately 1 week after the last administration of study drug during the multiple-dose period
Dose escalation will be dependent on safety parameters physical examination findings vital signs ECG studies adverse events and laboratory values and PK data
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