drugset / Trial / NCT02877264

A Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Formulations in Healthy Volunteers

NCT02877264 ↗

Phase 1 Completed 48 enrolled Aviragen Therapeutics
RandomizedCrossoverOpen-label

Summary

This is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet \[test drug\], 264 mg free base oral suspension \[test drug\], and two 132 mg phosphate salt capsules \[reference drug\]) in healthy volunteers. The study design consists of six dosing sequences. Each sequence comprises 3 periods and each subject is administered one of the three dosing formulations in the first period. A subject receives a different formulation in each of the subsequent periods, so that all subjects receive each formulation. The periods are separated by an approximate 7-day washout.

Timeline

Start
2016-06
Primary completion
2016-08
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Vapendavir Small molecule 264 mg Oral

Indications

No indication recorded.