Clinical trial NCT02204501: A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-Drug Interaction Healthy Volunteers
Keywords: Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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, 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: The Effect of Vapendavir on the PK Profile of Midazolam
timeFrame: End of Study (up to 46 weeks in duration)
measure: The Effect of Vapendavir on the PK Profile of Midazolam
timeFrame: End of Study (up to 46 weeks in duration)
Secondary outcomes:
measure: Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
timeFrame: End of Study (up to 46 weeks in duration)
measure: Assess the Safety of Vapendavir
timeFrame: End of Study (up to 46 weeks in duration
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Prism Clinical Research
state: Minnesota
Study officials:
affiliation: Prism Clinical Research
name: Mark Matson, MD
role: PRINCIPAL_INVESTIGATOR
References: