The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
Single doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day.
Richmond Pharmacology Ltd
London, United Kingdom
Time to maximum plasma concentration (tmax) for RV521
Time frame: Baseline to study day 11
Terminal half life (t1/2) for RV521
Time frame: Baseline to study day 11
Maximum observed plasma concentration (Cmax) for RV521
Time frame: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521
Time frame: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521
Time frame: Baseline to study day 11
Incidence of treatment emergent adverse events as assessed by CTCAE V5.0
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with morphological and/or rhythm abnormalities on ECG
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
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Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)