This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
adverse events at end of each cohort
Time frame: end of each cohort
hematology/chemistry/urinalysis at end of each cohort
Time frame: end of each cohort
physical examination at end of each cohort
Time frame: end of each cohort
vital signs and electrocardiogram (ECG) at end of each cohort
Time frame: end of each cohort
GSK626616 pharmacokinetics at end of each cohort
Time frame: end of each cohort
hemoglobin at end of each cohort
Time frame: end of each cohort
red blood cell measurements at end of each cohort
Time frame: end of each cohort
estimates of CYP enzyme activity at end of study
Time frame: end of study
mRNA levels in peripheral blood at end of study
Time frame: end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.