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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02101866

Run by

Biota Pharmaceuticals, Inc.

People needed

36

Starts

2014-03-01

Expected to finish

2014-06-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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