drugset / Trial / NCT02819102

An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates

NCT02819102

Phase 1 Completed 20 enrolled BioCryst Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353.

Timeline

Start
2016-03
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextromethorphan Unknown 30 mg Oral
Subject Midazolam Small molecule 1 mg Intravenous
Subject Midazolam Small molecule 2 mg Intravenous
Subject Omeprazole Other / unclassified 40 mg Oral
Subject Tolbutamide Small molecule 500 mg Oral
Subject berotralstat Small molecule 350 mg Oral

Indications