To evaluate the effect of coadministered cyclosporine on the pharmacokinetics of brincidofovir following simultaneous administration of SyB V-1901 with cyclosporine, or coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion in healthy adult subjects
This study is an open-label, randomized and crossover study designed to evaluate the effect of cyclosporine on the pharmacokinetics of SyB V-1901. Healthy adult subjects will receive an IV dose of SyB V-1901 alone, simultaneous administration of SyB V-1901 with cyclosporine, and coadministration of cyclosporine at 2 hours after completion of SyB V-1901 infusion. Eligible subjects will be randomized to one of two groups, to receive the treatment sequence of assigned group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
SyB V-1901 10 mg via IV infusion for 2 hours
200 mg Capsule
Research Site
Hachioji-shi, Tokyo, Japan
Maximum Plasma Concentration (Cmax) of brincidofovir (BCV)
Time frame: From initiation of SyB V-1901 administration though 16 days
Area under the plasma concentration versus time curve (AUC) of BCV
Time frame: From initiation of SyB V-1901 administration though 16 days
Cmax of cidofovir (CDV)
Time frame: From initiation of SyB V-1901 administration though 16 days
AUC of CDV
Time frame: From initiation of SyB V-1901 administration though 16 days
Cmax of Intercellular Cidofovir diphosphate (CDV-PP) in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: From initiation of SyB V-1901 administration though 18 days
AUC of Intercellular CDV-PP in PBMCs
Time frame: From initiation of SyB V-1901 administration though 18 days
Cmax of cyclosporine in blood
Time frame: From initiation of cyclosporine administration though 16 days
AUC of cyclosporine in blood
Time frame: From initiation of cyclosporine administration though 16 days
Number of subjects with adverse events (AE)
Time frame: Follow up 22 days post dose
Number of subjects with severity of AEs
Time frame: Follow up 22 days post dose
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Number of subjects with abnormal findings for laboratory parameters
Time frame: Follow up 22 days post dose
Number of subjects with abnormal findings for blood pressure
Time frame: Follow up 22 days post dose
Number of subjects with abnormal findings for respiratory rate
Time frame: Follow up 22 days post dose
Number of subjects with abnormal findings for heart rate
Time frame: Follow up 22 days post dose
Number of subjects with abnormal findings for temperature
Time frame: Follow up 22 days post dose