A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Drug-Drug Interaction Healthy Volunteers
Interventions
DRUG

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."

DRUG

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.

DRUG

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

Trial Locations (1)

55114

Prism Clinical Research, Saint Paul

All Listed Sponsors
lead

Biota Scientific Management Pty Ltd

INDUSTRY

NCT02204501 - A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers | Biotech Hunter | Biotech Hunter