A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive days.

The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy male volunteers.

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

Details

• Lead Sponsor: Sirtris, a GSK Company
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Be male within the age range of 18 to 55 years.

• Voluntarily sign an Independent Review Board (IRB/IEC)-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 Hematology, Coagulation, Clinical Chemistry 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 30.0 kg/m2.

• Be clear of any history of HIV 1 and 2 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.

• Subject and their partner must 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.

• Subject agrees to refrain from consumption of grapefruits and/or grapefruit juice from time of study enrollment through end of subject's final study visit.

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 unfavorable for enrollment.

• 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 Screening.

• Subject has a history of smoking, within 3 months, or is currently a smoker.

• Subject has a history of alcoholism (more than two years), 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.

• 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 or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the Screening period) prior to enrollment into the study.