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

Biota Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Vapendavir 300 mg tablet; Drug: Vapendavir 132 mg capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101866

BTA798-103

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Vapendavir 300 mg tablet

Experimental group

Description:

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

Treatment:

Drug: Vapendavir 300 mg tablet

Two Vapendavir 132 mg capsules

Experimental group

Description:

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

Treatment:

Drug: Vapendavir 132 mg capsules