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 |
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.
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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