HealthyPhase 1NCT02101866
A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers
A Phase 1 study testing Vapendavir 300 mg tablet and Vapendavir 132 mg capsules in people with Healthy, run by Biota Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vapendavir 300 mg tablet and Vapendavir 132 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Vapendavir 300 mg tablet, Vapendavir 132 mg capsules
- Keywords
- Bioavailability Study, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapendavir 300 mg tabletDrug
tablet - single dose
Vapendavir 132 mg capsulesDrug
2 capsules - single dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vapendavir 132 mg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: maximum up to 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, M.D., Principal investigator, Prism Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101866
- Sponsor's protocol ID
- BTA798-103
- Status last verified
- May 2018
- First submitted
- 24 Mar 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02101866
- Acronym / sponsor ID
- BTA798-103
- Conditions
- Healthy
- Keywords
- Bioavailability Study, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Biota Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapendavir 300 mg tablet | Experimental | Drug: Vapendavir 300 mg tabletVapendavir 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 | Experimental | Drug: Vapendavir 132 mg capsulesTwo Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vapendavir 300 mg tablettablet - single dose | Drug | Vapendavir 300 mg tablet |
| Vapendavir 132 mg capsules2 capsules - single dose | Drug | Two Vapendavir 132 mg capsules |
Primary outcome
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
Time frame: maximum up to 46 days
PK and statatistical analyses will be performed to determine the Primary Outcome Measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Matson, M.D. principal investigator
Prism Research, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vapendavir 300 mg tablet and Vapendavir 132 mg capsules in people with Healthy, run by Biota Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: maximum up to 46 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.