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

NCT02101866 | Completed Phase 1 DMC

• 1 other identifier: BTA798-103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability Study; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Outcome Measures

Primary Outcomes (1)

• 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

  PK and statatistical analyses will be performed to determine the Primary Outcome Measure

  maximum up to 46 days

Study Arms (2)

Vapendavir 300 mg tablet

EXPERIMENTAL

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

Drug: Vapendavir 300 mg tablet

Two Vapendavir 132 mg capsules

EXPERIMENTAL

Two Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose

Drug: Vapendavir 132 mg capsules

Interventions

Vapendavir 300 mg tablet DRUG

tablet - single dose

Vapendavir 300 mg tablet

Vapendavir 132 mg capsules DRUG

2 capsules - single dose

Two Vapendavir 132 mg capsules

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Biota Pharmaceuticals, Inc.: lead

Study Sites (1)

Investigative Site

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mark Matson, M.D.

  Prism Research, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

US (1)