Healthy
Conditions
Keywords
Bioavailability Study, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
Brief summary
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.
Interventions
DRUGVapendavir 300 mg tablet
tablet - single dose
DRUGVapendavir 132 mg capsules
2 capsules - single dose
Sponsors
Biota Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | maximum up to 46 days | PK and statatistical analyses will be performed to determine the Primary Outcome Measure |
Countries
United States
Outcome results
None listed