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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vapendavir 300 mg tablet

Intervention Type DRUG

tablet - single dose

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

Group Type EXPERIMENTAL

Vapendavir 132 mg capsules

Intervention Type DRUG

2 capsules - single dose

Interventions

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Vapendavir 300 mg tablet

tablet - single dose

Intervention Type DRUG

Vapendavir 132 mg capsules

2 capsules - single dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes