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

• Sponsor: Biota Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02101866
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Vapendavir 300 mg tablet; Drug: Vapendavir 132 mg capsules	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Vapendavir 300 mg tablet; tablet - single dose
Experimental: Two 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	Drug: Vapendavir 132 mg capsules; 2 capsules - single dose

Outcome Measures

Primary Outcome Measures

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 [maximum up to 46 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Saint Paul	Minnesota	United States	55101

Sponsors and Collaborators

• Biota Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Mark Matson, M.D., Prism Research, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biota Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02101866
• Other Study ID Numbers: BTA798-103
• First Posted: Apr 2, 2014
• Last Update Posted: May 30, 2018
• Last Verified: May 1, 2018

• Keywords provided by Biota Pharmaceuticals, Inc.: Bioavailability Study; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Study Results

No Results Posted as of May 30, 2018