Status:
COMPLETED
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers
Lead Sponsor:
Sirtris, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Healthy Volunteer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 on...
Detailed Description
Prospective, single center, clinical study of SRT2104 administered orally. Randomized, placebo-controlled, single-blind, multiple-dose, dose-escalation inpatient/outpatient study to assess the safety ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00933530
Start Date
May 1 2008
End Date
November 1 2008
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR