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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Vapendavir 300 mg tablet; Drug: Vapendavir 132 mg capsules

• Registration Number: NCT02101866
• Lead Sponsor: Biota Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-02
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vapendavir 300 mg tablet	Vapendavir 300 mg tablet	Vapendavir 300 mg tablet single dose with up to 7 day washout period followed by two vapendavir 132 mg capsules single dose
Two Vapendavir 132 mg capsules	Vapendavir 132 mg capsules	Two Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Saint Paul, Minnesota, United States