Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional basic science trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- The study is open to healthy male and female volunteers, 18 to 60 years of age, with hematology, clinical chemistry, electrolytes, serology, and urinalysis tests within normal, allowable limits using normal laboratory values (if out-of-range values result, they must be considered clinically significant by the Investigator to be exclusionary) and performed within 21 days to 1 day of receiving the first dose of test material.
- All male subjects and their female partners must be willing and able to use an acceptable form of double-barrier birth control (hormonal or double barrier method of birth control [condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository]; true abstinence) for at least 12 weeks after the last treatment dose.
- All female subjects must be of non-childbearing potential. For the purposes of this study, non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use adequate contraception (hormonal or double barrier method of birth control [condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository]; true abstinence) for the duration of the study dosing and for at least 12 weeks after the last treatment dose, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method].
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Experimental
Treatment Group
Subjects will be required to attend the research unit in a fasted state (at least 10 hours without food) on six separate occasions (treatment visits) during the study. At approximately the same time every morning, subjects will consume a standard, non-high-fat meal (approximately 650 kcal with 30% of calories derived from fat). Test material (per treatment) will be administered within 15-30 minutes following the meal. There will be at least a 7-day washout period between treatment visits. During the first five treatment visits, subjects will receive one of the following treatments in the form of 8 capsules: 0.25g SRT2104, 0.5g SRT2104, 1g SRT2104, 2g SRT2104, or placebo. During the last treatment visit, subjects will receive 30 mg of open-label prednisolone tablets.