Status:
COMPLETED
Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to assess the pharmacodynamic effect of single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone as measured by levels of ex vivo LPS-indu...
Detailed Description
This is a prospective, single center, non-therapeutic clinical study of SRT2104 administered orally as 250 mg capsules. Randomized, double-blind study to evaluate and compare the sensitivity of system...
Eligibility Criteria
Inclusion
- 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\].
Exclusion
Key Trial Info
Start Date :
April 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00920660
Start Date
April 6 2009
End Date
June 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