A Phase 1, Open-Label, Randomized, 2×2 Crossover Study of Pharmacodynamics Comparing the Impact of Tablet Size and Fasting Status With an Oral Human Influenza A/California/04/2009 (H1N1) HA Adenoviral-Vector Based Vaccine and dsRNA Adjuvant

Vaxart1 site in 1 country8 target enrollmentMarch 31, 2017

ConditionsSeasonal Influenza Preventative Vaccine Pharmacodynamics

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Seasonal Influenza Preventative Vaccine Pharmacodynamics
Sponsor: Vaxart
Enrollment: 8
Locations: 1
Primary Endpoint: PD: Location of disintegration
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.

Detailed Description

This is a pharmacodynamics study in healthy adult males. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, impacts the location and time of initial and complete disintegration of the drug product. The secondary objective is to evaluate delivery with fasting versus fed status.

Registry

clinicaltrials.gov

Start Date

March 31, 2017

End Date

April 3, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Vaxart

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male volunteers aged 18 - 49 years, inclusive
•Willing and able to give written informed consent/HIPAA authorization form
•In good health (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, vital signs and laboratory tests at screening
•Liver function tests (alanine aminotransferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), direct bilirubin (DB) and total bilirubin (TB) are within the normal range. \[N.B., an elevated TB in the absence of an elevated direct bilirubin (benign unconjugated hyperbilirubinemia, known as Gilbert's Syndrome) will not be exclusionary\]
•Body weight ≥ 50 kg and a Body mass index between 17 and 35 at screening
•Willingness to abstain from caffeine or xanthine containing foods or beverages, alcohol, tobacco or nicotine-containing products and strenuous exercise from 72 hours prior to screening and each dosing until discharge post each Dosing Day.
•Dietary habits that fall within the range of normal, as determined by the Investigator. Examples of abnormal diets are liquid diets, protein only diets, high fat diets, or low carbohydrate diets.
•Verbal confirmation from subject that his bowel movements are regular.
•Comprehension of the study requirements (in English) with ability and willingness to complete all assessments and comply with scheduled visits and contacts.

Exclusion Criteria

•Administration of any vaccine within 4 weeks preceding DP administration or during the study through the active period (Day 36), or any licensed or investigational adjuvanted vaccine within 12 months preceding DP administration, or planned use of any licensed or investigational adjuvanted vaccine during the study through the 12-month safety follow- up period
•Use of any investigational drug or device the greater of: within 4 weeks preceding DP administration, or planned use of the above stated during the study through the study active period (Day 36) OR within 5 half-lives of an investigational drug product
•Use of concomitant medications that may interfere with normal gastrointestinal tract function, including but not limited to those listed below:
•Proton pump inhibitors
•H2 blockers
•GI motility stimulants (e.g. metoclopramide)
•Anti-nausea/anti-emetics
•Opiate class pain relievers
•Anti-diarrheals
•Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening