Status:
COMPLETED
A Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers
Lead Sponsor:
Sirtris, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal healthy male and ...
Eligibility Criteria
Inclusion
- Be a healthy male or female within the age range of 18 to 55 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 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/m\^2.
- 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.
- All subjects 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.
- All female subjects must be of non-childbearing potential. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. (Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) of 20 - 138 mIU/ml and oestradiol \< 20 pg/ml at entry. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor.
- Subject agrees 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.
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 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).
- 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 (with the exception of hormone replacement therapy for female subjects) 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 :
January 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00938275
Start Date
January 20 2009
End Date
March 27 2009
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR