Status:
COMPLETED
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
MALE
18-60 years
Phase:
PHASE1
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 sing...
Detailed Description
This is a prospective, single center, clinical study of SRT2104 administered orally; a randomized, inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in healthy male ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00933062
Start Date
March 23 2009
End Date
May 12 2009
Last Update
July 7 2017
Active Locations (1)
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1
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR