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

NCT02877264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-11-26

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

vapendavir 132 mg capsule

DRUG

vapendavir 264 mg tablet

DRUG

vapendavir 24 mg/mL oral suspension

Sponsors & Collaborators

  • Aviragen Therapeutics

    lead INDUSTRY

Principal Investigators

  • Anna Novotney-Barry · Aviragen Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02877264 on ClinicalTrials.gov