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 female volunteers in both the fed and fasted state. The secondary objective is to assess the safety and tolerance of SRT2104 administered as an oral suspension and as a capsule formulation to healthy male and female volunteers in both the fed and fasted state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
SRT2104 will be supplied in two forms: as 0.5g powder which will be prepared by the pharmacist/designee into a liquid suspension and as two hard gelatin capsules, each containing 0.25g SRT2104. The dosing vehicle for the liquid suspension is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Each formulation of test material will be administered orally, in a single dose to the subjects in the fasted state and following consumption of a standard meal. Neither the investigator nor the subjects enrolled will be blinded to treatment assignment.
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom
Characterize and compare the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and as a capsule formulation.
Time frame: PK time points: pre-dose (0 hrs); 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0. 6.0, 8.0, 10, 12, 15, 24, 36, 48, 72 hours post dose.
Assess the safety and tolerance of SRT2104.
Time frame: AEs, concomitant medications (as applicable), vital signs, physical examinations, laboratory parameters, and ECG parameters will be collected for the duration of the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.