Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers

NCT00933062 | Completed Phase 1

• 1 other identifier: 113140
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• To assess the plasma pharmacokinetic profile of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.

  Plasma samples will be collected pre-dose (0 h) and at the following time points following dosing on Days 1 and 21: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 48, 72 and 168 h post-dose.

Secondary Outcomes (1)

• To assess the safety and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.

  Safety will be monitored by AEs, VS, physical exam, labs and ECGs during the study.

Study Arms (2)

SRT2104

ACTIVE COMPARATOR

Subjects will receive a dose of 2.0 g SRT2104 (administered as eight 250 mg capsules) on eight occasions during the study; once as a single dose (study day 1) during Treatment Period 1, and once per day for seven consecutive days (study days 15 to 21) during Treatment Period 2.

Drug: SRT2104

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo on eight occasions during the study; once as a single dose (study day 1) during Treatment Period 1, and once per day for seven consecutive days (study days 15 to 21) during Treatment Period 2.

Drug: Placebo

Interventions

SRT2104 DRUG

2.0 g of SRT2104 will be supplied in hard gelatin capsules each containing 250 mg SRT2104. SRT2104 will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of SRT2104 will be orally-administered with approximately 200 mL water.

SRT2104

Placebo DRUG

Placebo will be supplied in hard gelatine capsules containing an appropriate amount of placebo. Placebo will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of placebo will be orally-administered with approximately 200 mL water.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a healthy male within the age range of 18 to 60 years.
• Voluntarily sign a Research Ethics Committee (REC)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
• Have a BMI (Body Mass Index) between 18.0 and 32.0 kg/m2.
• Be clear of any history of HIV and hepatitis B and C.
• Have no significant disease or clinically significant abnormal laboratory value as deemed by the investigator on the laboratory evaluations, medical history, or physical exam.
• Have a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
• Have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
• Agree to use an acceptable double barrier method for birth control from the Screening visit through 3 months after the last dose of test material.
• Agree to refrain from consumption of grapefruits and/or grapefruit juice from 7 days prior to Day -1 of treatment visit 1 through to the end of subject's final study visit on Day 29.

You may not qualify if:

• Subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the Investigator would deem unfavourable for enrolment.
• Subject has renal or liver impairment.
• Subject has a history of gastro-intestinal surgery or has a current gastrointestinal disease which may influence drug absorption.
• Subject has a history, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC) or a positive drug result at the Screening Visit.
• Subject smokes more than 5 cigarettes a day.
• Subject has a history of alcoholism, and/or is currently drinking more than three drinks per day \[one drink is equal to one unit of alcohol (one glass of wine, half a pint of beer, one measure of a spirit)\].
• Subject has participated in a clinical trial within the past three months (defined as three months from the date of last dose of an investigational medicinal product), with the exception of the SRT-2104-004 study (EudraCT number: 2008-007364-41).
• Subject has a history of difficulty in donating blood or accessibility of veins in left or right arm.
• Subject has donated blood (one unit or 350 mL) within three months prior to receiving test material.
• Subject is taking herbal products, over-the-counter medication or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the Screening Period) prior to enrolment into the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Merthyr Tydfill, Glamorgan, CF48 4DR, United Kingdom

Location

Related Publications (1)

• Hoffmann E, Wald J, Lavu S, Roberts J, Beaumont C, Haddad J, Elliott P, Westphal C, Jacobson E. Pharmacokinetics and tolerability of SRT2104, a first-in-class small molecule activator of SIRT1, after single and repeated oral administration in man. Br J Clin Pharmacol. 2013 Jan;75(1):186-96. doi: 10.1111/j.1365-2125.2012.04340.x.

  PMID: 22616762 BACKGROUND

Related Links

• Results for study 113140 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SRT2104

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: July 7, 2009
• Study Start: March 23, 2009
• Primary Completion: May 12, 2009
• Study Completion: May 12, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)