Advertisement

Topics

A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers

2014-08-27 03:17:49 | BioPortfolio

Summary

The main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 (25, 75, 250, 500, 1000, 2000, and 3000 mg/day [fasted] and 500 mg/day [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.

Description

Prospective, single center, clinical study of SRT2379 administered orally. Randomized, placebo-controlled, single-blind, multiple-dose, dose-escalation inpatient/outpatient 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 inclusion/exclusion criteria, will be enrolled in this study. Eight cohorts of eight subjects each will be examined. Subjects within each cohort will be randomized 6:2 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 mg/day 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Conditions

Diabetes Mellitus, Type 2

Intervention

SRT2379, Placebo

Location

GSK Investigational Site
Merthyr Tydfill
Glamorgan
United Kingdom
CF48 4DR

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:49-0400

Clinical Trials [4662 Associated Clinical Trials listed on BioPortfolio]

MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

ECG Changes Including QT Dispersion and Corrected QT Prolongation in Children and Adolescents With Type 1 Diabetes

Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes...

A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG 108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c fro...

Monotherapy Study in Patients With Type 2 Diabetes Mellitus

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus

Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ...

PubMed Articles [10356 Associated PubMed Articles listed on BioPortfolio]

Efficacy of metformin on glycemic control and weight in drug-naive type 2 diabetes mellitus patients: A systematic review and meta-analysis of placebo-controlled randomized trials.

Metformin is recommended as the first-line treatment of type 2 diabetes mellitus. Despite its common use, few studies have been conducted to precisely measure the efficacy of metformin versus placebo ...

Diabetes-related cognitive dysfunction:Hyperglycemia in the early stage may be a key?

Type 2 diabetes mellitus has been an established risk factor for cognitive decline, which is recently recognized as a new type of diabetes-related complication. Although wide-range of cognitive domain...

Weekly glucagon-like peptide-1 receptor agonist albiglutide as monotherapy improves glycemic parameters in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study.

This phase 3, randomized, double-blind 24-week study with extension to 1 year assessed efficacy and safety of albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus (T2DM...

Beneficial Effects of n-3 Fatty Acids on Cardiometabolic and Inflammatory Markers in Type 2 Diabetes Mellitus: A Randomized Placebo-Controlled Double-blind Clinical Trial.

To determine the effect of n-3 polyunsaturated fatty acids (n-3PUFAs) supplementation on circulatory resistin and monocyte chemoattractant 1 (MCP-1) levels in type 2 diabetes mellitus (T2DM) patients.

Effect of Aloe vera on glycemic outcomes in patients with diabetes mellitus: a systematic review protocol.

The objective is to identify the effectiveness of Aloe vera on glycemic outcomes (fasting blood glucose level and glycosylated hemoglobin) in patients with diabetes mellitus. Specifically, the review ...

Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

More From BioPortfolio on "A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial