This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a single dose of GSK962040. The results from this study will help to estimate the maximum increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also contain an exploratory investigation of biliary secretion of GSK962040 and or its metabolites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
GSK962040. Planned doses per cohort as follows: Cohort 1 planned dose = 10 mg; Cohort 2 to be determined based on data from Cohort 1
400 mg
GSK Investigational Site
Buffalo, New York, United States
Pharmacokinetic parameters (AUC(0-inf), and Cmax) of GSK962040
Time frame: Duration of dosing
Safety and tolerability assessments, consisting of AEs, ECGs, vital signs, clinical laboratory tests.
Time frame: Duration of dosing
Additional pharmacokinetic parameters of GSK962040, i.e., tmax, t1/2, AUC(0-t)
Time frame: Duration of dosing
To characterize the nature of the GSK962040-related material in plasma, 24-hour urine, and bile.
Time frame: 24 h
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.