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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Vapendavir 300 mg tablet
* Drug: Vapendavir 132 mg capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vapendavir 300 mg tablet<br>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<br>* tablet - single dose<br>|
| Experimental: Two Vapendavir 132 mg capsules<br>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<br>* 2 capsules - single dose<br>|

What is the study measuring?
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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 | PK and statatistical analyses will be performed to determine the Primary Outcome Measure | maximum up to 46 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability Study, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen