A Study to Compare the Oral Bioavailability of Single Doses of Three Vapendavir Drug Formulations in Healthy Volunteers
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55114
- Aviragen Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Vapendavir Capsule, 264 mg
Vapendavir phosphate salt administered orally as a single dose of two 132 mg hard gelatin capsules
|
Other Names:
|
|
Experimental: Vapendavir Tablets, 264 mg
Vapendavir free base tablets containing 264 mg of vapendavir
|
Other Names:
|
|
Experimental: Vapendavir Oral Suspension, 264 mg
Vapendavir free base as a 24 mg/mL oral suspension
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relative oral bioavailability, as applicable
Time Frame: Study Day 0 - 17
|
Study Day 0 - 17
|
|
Maximum observed plasma concentration (Cmax)
Time Frame: Study Day 0 - 17
|
Study Day 0 - 17
|
|
Time at which Cmac was observed (Tmax)
Time Frame: Study Day 0 - 17
|
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
|
Study Day 0 - 17
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- BTA798-104
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