A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
47
Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd
London, United Kingdom
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
Time frame: Up to 14 days
Measurement of the concentrations of V565 in ileal fluid following a single dose
Time frame: 24 hours
Evaluation of pharmacokinetic parameter of V565: Cmax
Time frame: 72 hours
Evaluation of pharmacokinetic parameter of V565: AUC
Time frame: 72 hours
Evaluation of pharmacokinetic parameter of V565: tmax
Time frame: 72 hours
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Open-label single dose
Open-label single ascending dose