24
Participants
Start Date
May 31, 2014
Primary Completion Date
June 30, 2014
Study Completion Date
June 30, 2014
Midazolam 5mg Syrup
"All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.~* On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.~* On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B."
Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Prism Clinical Research, Saint Paul
Biota Scientific Management Pty Ltd
INDUSTRY