A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
Psoriasis

About this trial
This is an interventional other trial for Psoriasis focused on measuring SRT2104, Modified Release, Bioavailability, Crossover
Eligibility Criteria
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician.
- Males between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight >=50 kilogram (kg) (110 lbs) and body mass index (BMI) >=18.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures or compromise the subject's safety.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), or aspartate aminotranferase (AST), alanine aminotranferase (ALT), alkaline phosphatase and bilirubin >1.5 x upper limit of normal (ULN).
- Abnormalities on the Screening or Day -1: electrocardiogram (ECG) that, in the opinion of the investigator, will compromise subject safety in the study or QT corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec).
- A history of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV), or positive serology at Screening.
- History of regular alcohol consumption within 6 months of the Screening (Screening visit) and a positive pre-study drug/alcohol screen.
- Participation in a clinical trial and treatment with an investigational product within 3 months prior to Screening visit.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that contraindicates their participation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Where participation in the study would result in the inability to donate blood or blood products in excess of 500 milliliter (mL) within a 56 day period.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1: Cap SRT2104
Part 1: Tab SRT2104 (slow release)
Part 1: Tab SRT2104 (intermediate release)
Part 1: Tab SRT2104 (fast release)
Part 2A: SRT2104 500 mg single-dose
Part 2B: SRT2104 single alternative dose
Part 2C: SRT2104 500 mg daily for 7 days
500 mg SRT2104 (in the form of two, 250 mg capsules) will be administered as a single oral dose in the fasting state
500 mg SRT2104 (in the form of two, 250 mg slow release tablets) will be administered as a single oral dose in the fasting state.
500 mg SRT2104 (in the form of two, 250 mg intermediate release tablets) will be administered as a single oral dose in the fasting state.
500 mg SRT2104 (in the form of two, 250 mg fast release tablets) will be administered as a single oral dose in the fasting state.
500 mg SRT2104 (formulation selected from Part 1) will be administered as a single oral dose in the fed state.
An alternative dose (other than 500 mg, but not to exceed 2000 mg) of SRT2104 (formulation selected from Part 1) will be administered as a single oral dose.
500 mg SRT2104 (formulation selected from Part 1) will be administered daily for 7 days.