Drug-Drug Interaction Healthy VolunteersPhase 1NCT02204501
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
A Phase 1 study testing Midazolam 5mg Syrup, Vapendavir 264 mg BID and Vapendavir 528 mg QD in people with Drug-Drug Interaction Healthy Volunteers, run by Biota Scientific Management Pty Ltd at 1 site in United States.
Trial summary
The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction Healthy Volunteers
- What is being tested?
- Midazolam 5mg Syrup, Vapendavir 264 mg BID and Vapendavir 528 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 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, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
- Female subjects who are not post-menopausal 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); and
- Female subjects must not be breastfeeding or pregnant.
Who cannot join
- Positive results for Hepatitis B, Hepatitis C, or HIV;
- Frequent use (defined as > 5 times/day) 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 (defined as within 14 days of first study visit participation)
- Presence or history of significant allergy;
- Clinically significant abnormalities noted on ECG;
Show all 13Show fewer
- Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.
- Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
- 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; and
- Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Clinical Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers
The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.
- Conditions
- Drug-Drug Interaction Healthy Volunteers
- Being tested
- Midazolam 5mg Syrup, Vapendavir 264 mg BID, Vapendavir 528 mg QD
- Keywords
- 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.
Midazolam 5mg SyrupDrug
All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.
- On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
- On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.
Vapendavir 264 mg BIDDrug
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
Vapendavir 528 mg QDDrug
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
| Study group | Role | What they receive |
|---|---|---|
| Vapendavir 528 mg QD | Experimental | Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days Receives: Drug: Midazolam 5mg Syrup; Drug: Vapendavir 528 mg QD |
| Vapendavir 264 mg BID | Experimental | Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days. Receives: Drug: Midazolam 5mg Syrup; Drug: Vapendavir 264 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Vapendavir on the PK Profile of Midazolam
To evaluate the effect of vapendavir daily dose of 264 mg BID on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:
- for midazolam including maximum observed plasma concentration (Cmax)
- time at which Cmax was observed (Tmax)
- plasma concentration at the end of the dosing interval (Ctau)
- area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
- area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
- area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
- elimination half-life (t1/2)
- apparent oral clearance (CL/F)
- apparent oral volume of distribution (Vz/F).
Measured: End of Study (up to 46 weeks in duration)
The Effect of Vapendavir on the PK Profile of Midazolam
To evaluate the effect of vapendavir daily dose of 528 mg QD on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:
- for midazolam including maximum observed plasma concentration (Cmax)
- time at which Cmax was observed (Tmax)
- plasma concentration at the end of the dosing interval (Ctau)
- area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
- area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
- area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
- elimination half-life (t1/2)
- apparent oral clearance (CL/F)
- apparent oral volume of distribution (Vz/F).
Measured: End of Study (up to 46 weeks in duration)
Secondary outcomes (2)
Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
To evaluate whether the PK profile of vapendavir, is affected by the presence of midazolam, a strong CYP3A4 substrate. This outcome will be evaluated through a series of analyses of PK parameters for vapendavir including:
- maximum observed plasma concentration (Cmax)
- time at which Cmax was observed (Tmax)
- plasma concentration at the end of the dosing interval (Ctau)
- area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
- area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
- area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
- elimination half-life (t1/2)
- apparent oral clearance (CL/F)
- apparent oral volume of distribution (Vz/F).
Measured: End of Study (up to 46 weeks in duration)
Assess the Safety of Vapendavir
To evaluate the safety of vapendavir. This will be accomplished by assessing adverse events, clinical laboratory tests (including blood chemistry, hematology with differential and urinalysis), physical exams, ECG assessments, vital sign assessments and concomitant medications.
Measured: End of Study (up to 46 weeks in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 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 Drug-Drug Interaction Healthy VolunteersStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Scientific Management Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, MD, Principal investigator, Prism Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204501
- Sponsor's protocol ID
- BTA798-102
- Status last verified
- May 2018
- First submitted
- 27 May 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
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 Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02204501
- Acronym / sponsor ID
- BTA798-102
- Conditions
- Drug-Drug Interaction Healthy Volunteers
- Keywords
- Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jul 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.
The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapendavir 528 mg QD | Experimental | Drug: Midazolam 5mg Syrup, Drug: Vapendavir 528 mg QDTwelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days |
| Vapendavir 264 mg BID | Experimental | Drug: Midazolam 5mg Syrup, Drug: Vapendavir 264 mg BIDTwelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days. |
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, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
- Female subjects who are not post-menopausal 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); and
Key exclusion criteria (13 listed)
- Positive results for Hepatitis B, Hepatitis C, or HIV;
- Frequent use (defined as > 5 times/day) 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 (defined as within 14 days of first study visit participation)
- Presence or history of significant allergy;
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 |
|---|---|---|
| Midazolam 5mg SyrupAll twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days. * On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning. * On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B. | Drug | Vapendavir 264 mg BID, Vapendavir 528 mg QD |
| Vapendavir 264 mg BIDTwelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days. | Drug | Vapendavir 264 mg BID |
| Vapendavir 528 mg QDTwelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days | Drug | Vapendavir 528 mg QD |
Primary outcome
The Effect of Vapendavir on the PK Profile of Midazolam
Time frame: End of Study (up to 46 weeks in duration)
To evaluate the effect of vapendavir daily dose of 264 mg BID on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including: * for midazolam including maximum observed plasma concentration (Cmax) * time at which Cmax was observed (Tmax) * plasma concentration at the end of the dosing interval (Ctau) * area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last) * area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau) * area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) * elimination half-life (t1/2) * apparent oral clearance (CL/F) * apparent oral volume of distribution (Vz/F).
The Effect of Vapendavir on the PK Profile of Midazolam
Time frame: End of Study (up to 46 weeks in duration)
To evaluate the effect of vapendavir daily dose of 528 mg QD on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including: * for midazolam including maximum observed plasma concentration (Cmax) * time at which Cmax was observed (Tmax) * plasma concentration at the end of the dosing interval (Ctau) * area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last) * area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau) * area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) * elimination half-life (t1/2) * apparent oral clearance (CL/F) * apparent oral volume of distribution (Vz/F).
2 secondary outcomes
Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
Time frame: End of Study (up to 46 weeks in duration)
Assess the Safety of Vapendavir
Time frame: End of Study (up to 46 weeks in duration
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.
Related trials for Drug-Drug Interaction Healthy Volunteers
RecruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
Healthy Volunteer Study, Healthy Adults
Not yet recruitingPhase 1
Effect of Itraconazole on the Pharmacokinetics of Intravenous HRS-4642 in Healthy Participants
Drug Interactions
RecruitingPhase 1
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
Healthy Adult Participants
Active, not recruitingPhase 1
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
Healthy Volunteer
RecruitingPhase 1
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Drug-drug Interaction
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, MD principal investigator
Prism Clinical Research
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 Midazolam 5mg Syrup, Vapendavir 264 mg BID and Vapendavir 528 mg QD in people with Drug-Drug Interaction Healthy Volunteers, run by Biota Scientific Management Pty Ltd 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 13 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?
The Effect of Vapendavir on the PK Profile of Midazolam (time frame: End of Study (up to 46 weeks in duration)). The study lists 2 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 30 May 2018.