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

• Status: Completed
• Trial end date: 2009-05-12
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• 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 biochemistry, coagulation, haematology and urinalysis test results that are within normal, allowable limits (if out-of-range, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of test material.

• 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.

Exclusion Criteria:

• 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.