HealthyPhase 1NCT02877264
A Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Formulations in Healthy Volunteers
A Phase 1 study testing vapendavir 132 mg capsule, vapendavir 264 mg tablet and vapendavir 24 mg/mL oral suspension in people with Healthy, run by Aviragen Therapeutics at 1 site in United States.
Trial summary
This is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral suspension [test drug], and two 132 mg phosphate… Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- vapendavir 132 mg capsule, vapendavir 264 mg tablet and vapendavir 24 mg/mL oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2016
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a healthy male or female between 19 and 60 years of age (inclusive) at the time of signing the informed consent and weigh ≥50 kg with a BMI between 18 and 32.0 kg/m2 (inclusive);
- 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, VS, ECGs, and clinical laboratory tests;
- Female subjects who are not postmenopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects, who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository) from Study Day 0 until 30 days after completion of the study. This includes female subjects who are using hormonal contraception;
- Female subjects must not be breastfeeding or pregnant.
Who cannot join
- Positive results at screening for hepatitis B, hepatitis C, or HIV;
- No use of tobacco products, as well as electronic cigarettes, within 14 days of Study Day 1 or unwilling to abstain during study participation;
- A medical history or clinical evidence of any clinical condition that may, in the opinion of the Investigator or Medical Monitor, impact on the subject's ability to participate in the study, or on the study results;
- Current or recent respiratory or other infection within 14 days of screening;
- Presence or history of significant allergy requiring treatment;
- Clinically significant abnormalities on ECG;
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- Vital signs representing abnormal systolic blood pressure and/or abnormal diastolic blood pressure;
- Safety laboratory abnormalities at screening or Study Day 0 which are clinically significant;
- Subject has a history of drug abuse or alcohol abuse in the past 2 years or current evidence of such abuse or addiction;
- A positive urine drug screen test at screening or admission to the study facility;
- A positive breathalyzer for alcohol at screening or admission to the study facility;
- A positive pregnancy test at screening or admission to the study facility;
- Abstinence from alcohol must be employed from 72 hours before Study Day 1 and throughout the duration of study participation;
- Use of chronic prescription medications within 90 days, with the exception of hormonal contraceptives (or contraceptive device containing hormonal contraceptive) being taken by female subjects within 14 days, or over-the-counter (OTC) medications, including vitamin, herbal, and mineral supplements, within the 7 days prior to Study Day 1 and throughout study participation;
- Received an investigational drug or investigational vaccine within 30 days, or use of an investigational medical device within 30 days prior to Study Day 1;
- Any prior use of vapendavir or inclusion in a previous vapendavir investigational study or ongoing participation in a vapendavir investigational study;
- Donation or loss of whole blood within 60 days or plasma within 14 days of Study Day 1 or anytime from screening to 30 days after completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aviragen Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: A Randomized, Single-Center, Open-Label, Three-Period, Six-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Product Formulations in Healthy Volunteers
This is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy volunteers. The study design consists of six dosing sequences. Each sequence comprises 3 periods and each subject is administered one of the three dosing formulations in the first period. A subject receives a different formulation in each of the subsequent periods, so that all subjects receive each formulation. The periods are separated by an approximate 7-day washout.
Read the detailed description
Owner of Study Record: Vaxart Inc.
- Conditions
- Healthy
- Being tested
- vapendavir 132 mg capsule, vapendavir 264 mg tablet, vapendavir 24 mg/mL oral suspension
- Keywords
- Vapendavir, Bioavailability, Biological Availability, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vapendavir 132 mg capsuleDrug
Also called BTA798
vapendavir 264 mg tabletDrug
Also called BTA798
vapendavir 24 mg/mL oral suspensionDrug
Also called BTA798
| Study group | Role | What they receive |
|---|---|---|
| Vapendavir Capsule, 264 mg | Experimental | Vapendavir phosphate salt administered orally as a single dose of two 132 mg hard gelatin capsules Receives: Drug: vapendavir 132 mg capsule |
| Vapendavir Tablets, 264 mg | Experimental | Vapendavir free base tablets containing 264 mg of vapendavir Receives: Drug: vapendavir 264 mg tablet |
| Vapendavir Oral Suspension, 264 mg | Experimental | Vapendavir free base as a 24 mg/mL oral suspension Receives: Drug: vapendavir 24 mg/mL oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative oral bioavailability, as applicable
Measured: Study Day 0 - 17
Maximum observed plasma concentration (Cmax)
Measured: Study Day 0 - 17
Time at which Cmac was observed (Tmax)
Measured: Study Day 0 - 17
Area under the plasma concentration time curve from time ) to the last measureable plasma concentration (AUC 0-last)
Measured: Study Day 0 - 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aviragen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Aviragen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877264
- Sponsor's protocol ID
- BTA798-104
- Status last verified
- Nov 2018
- First submitted
- 15 Aug 2016
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Open-Label, Three-Period, Six-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Product Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02877264
- Acronym / sponsor ID
- BTA798-104
- Conditions
- Healthy
- Keywords
- Vapendavir, Bioavailability, Biological Availability, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aviragen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- First posted
- 24 Aug 2016 (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 is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy volunteers. The study design consists of six dosing sequences. Each sequence comprises 3 periods and each subject is administered one of the three dosing formulations in the first period. A subject receives a different formulation in each of the subsequent periods, so that all subjects receive each formulation. The periods are separated by an approximate 7-day washout.
Detailed description
Owner of Study Record: Vaxart Inc.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vapendavir Capsule, 264 mg | Experimental | Drug: vapendavir 132 mg capsuleVapendavir phosphate salt administered orally as a single dose of two 132 mg hard gelatin capsules |
| Vapendavir Tablets, 264 mg | Experimental | Drug: vapendavir 264 mg tabletVapendavir free base tablets containing 264 mg of vapendavir |
| Vapendavir Oral Suspension, 264 mg | Experimental | Drug: vapendavir 24 mg/mL oral suspensionVapendavir free base as a 24 mg/mL oral suspension |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be a healthy male or female between 19 and 60 years of age (inclusive) at the time of signing the informed consent and weigh ≥50 kg with a BMI between 18 and 32.0 kg/m2 (inclusive);
- 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, VS, ECGs, and clinical laboratory tests;
- Female subjects who are not postmenopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects, who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository) from Study Day 0 until 30 days after completion of the study. This includes female subjects who are using hormonal contraception;
Key exclusion criteria (17 listed)
- Positive results at screening for hepatitis B, hepatitis C, or HIV;
- No use of tobacco products, as well as electronic cigarettes, within 14 days of Study Day 1 or unwilling to abstain during study participation;
- A medical history or clinical evidence of any clinical condition that may, in the opinion of the Investigator or Medical Monitor, impact on the subject's ability to participate in the study, or on the study results;
- Current or recent respiratory or other infection within 14 days of screening;
- Presence or history of significant allergy requiring treatment;
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 132 mg capsuleAlso: BTA798 | Drug | Vapendavir Capsule, 264 mg |
| vapendavir 264 mg tabletAlso: BTA798 | Drug | Vapendavir Tablets, 264 mg |
| vapendavir 24 mg/mL oral suspensionAlso: BTA798 | Drug | Vapendavir Oral Suspension, 264 mg |
Primary outcome
Relative oral bioavailability, as applicable
Time frame: Study Day 0 - 17
Maximum observed plasma concentration (Cmax)
Time frame: Study Day 0 - 17
Time at which Cmac was observed (Tmax)
Time frame: Study Day 0 - 17
Area under the plasma concentration time curve from time ) to the last measureable plasma concentration (AUC 0-last)
Time frame: Study Day 0 - 17
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 26 Nov 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.
Anna Novotney-Barry study director
Aviragen Therapeutics, 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 132 mg capsule, vapendavir 264 mg tablet and vapendavir 24 mg/mL oral suspension in people with Healthy, run by Aviragen Therapeutics 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 17 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 26 Nov 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?
Relative oral bioavailability, as applicable (time frame: Study Day 0 - 17). The study lists 4 primary outcomes in all. 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 26 Nov 2018.