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Completed

NCT Number: NCT02101866

A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site

Saint Paul, Minnesota, 55101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapendavir 300 mg tablet

Drug

tablet - single dose

Vapendavir 132 mg capsules

Drug

2 capsules - single dose

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Biota Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2014
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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