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

May 29, 2018 updated by: Biota Pharmaceuticals, Inc.

A Randomized, Single-Center, Open-Label, Two-Period, Two-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Product Formulations in Healthy Volunteers

This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening
  • Capable of giving written informed consent
  • Subject is able to understand and comply with the protocol requirements, instructions and restrictions
  • Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests
  • Female subjects must be of non-childbearing potential
  • Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

  • Positive results for Hepatitis B, Hepatitis C, or HIV
  • Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco
  • A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection
  • Presence or history of significant allergy
  • Clinically significant abnormalities noted on ECG
  • Screening vital signs representing sustained elevated blood pressure
  • Presence of significant gastrointestinal abnormalities
  • Safety laboratory abnormalities noted at screening which are clinically significant
  • Current or defined history of abuse of alcohol or illicit drugs
  • A positive pregnancy test at screening
  • Poor vein access or fear of venipuncture or sight of blood

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vapendavir 300 mg tablet
Vapendavir 300 mg tablet single dose with up to 7 day washout period followed by two vapendavir 132 mg capsules single dose
Drug: Vapendavir 300 mg tablet
tablet - single dose
Experimental: Two Vapendavir 132 mg capsules
Two Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose
Drug: Vapendavir 132 mg capsules
2 capsules - single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic exposure profile of a single dose of a vapendavir 300 mg tablet compared to the exposure profile following a single dose of two 132 mg vapendavir capsules
Time Frame: maximum up to 46 days
PK and statatistical analyses will be performed to determine the Primary Outcome Measure
maximum up to 46 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biota Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Mark Matson, M.D., Prism Research, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BTA798-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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