This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
This study is a Phase I open label drug interaction study with two objectives. The first objective of this study (Cohort 1) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of omeprazole, a proton-pump inhibitor that is commonly used by chronic hepatitis C patients . The second objective of this study (Cohort 2) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of ritonavir, a HIV protease inhibitor drug that is a potent inhibitor of CYP 3A4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
GSK2336805 and Omeprazole
GSK2336805 and Ritonavir
GSK Investigational Site
Buffalo, New York, United States
area under the plasma concentration time curve from time zero to the last quantifiable time points
PK parameter
Time frame: 48 hours
under the plasma concentration time curve from time zero to infinity
PK parameter
Time frame: 48 hours
area under the plasma concentration time curve from time zero to 24 hours
PK parameter
Time frame: 24 hours
maximum observed concentration
PK parameter
Time frame: 48 hours
time to maximum observed concentration
PK parameter
Time frame: 48 hours
concentration at 24 hours post-dose
PK parameter
Time frame: 24 hours
last measureable concentration
PK parameter
Time frame: 48 hours
time of last measurable concentration
PK parameter
Time frame: 48 hours
absorption lag time
PK parameter
Time frame: 48 hours
the elimination half-life
PK parameter
Time frame: 48 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
apparent oral clearance
PK parameter
Time frame: 48 hours
apparent volume of distribution
PK parameter
Time frame: 48 hours
Number of subjects with Adverse Events
Safety parameter
Time frame: 24 hours
Number of subjects needing concurrent medications
Safety parameter
Time frame: 24 hours
Number of subjects with clinical laboratory tests of clinical significance
Safety parameter
Time frame: 24 hours
Number of subjects with electrocardiograms with clinically significant values
Safety parameter
Time frame: 24 hours
Number of subjects with vital sign measures of clinical significance
Safety parameter
Time frame: 24 hours