A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Active
Placebo
KalVista Investigative Site
Wales, United Kingdom
Number of Subjects with Adverse Events
Time frame: Change from pre-dose to last visit, 5-7 days post dose.
Number of Subjects with Serious Adverse Events
Time frame: Change from pre-dose to last visit, 5-7 days post dose.
Number of participants with clinically significant changes in laboratory assessments
Time frame: Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in vital signs
Time frame: Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements
Time frame: Throughout study until last visit, 5-7 days post dose.
Pharmacokinetics - Cmax
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-t
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-24
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 24 hours post dose
Pharmacokinetics - AUC0-inf
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 48 hours post dose
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Pharmacokinetics - food effect (Part C only)
90% confidence intervals of the ratios for AUC0-t and Cmax with and without food lie in the range 80-125
Time frame: Up to 24 hours post dose
Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)
90% confidence intervals of the ratios for AUC0-t and Cmax between the two dosages lie in the range 80-125
Time frame: Up to 24 hours post dose