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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:6/1/2018
Start Date:March 2014
End Date:June 2014

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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

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.


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
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