Hereditary Angioedema
Conditions
Brief summary
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
Detailed description
In this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of BCX7353 and one of the formulations administered with a high-fat meal. A 14-day washout period will separate each dose.
Interventions
DRUGBCX7353
BCX7353
Sponsors
BioCryst Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* written informed consent * acceptable birth control measures for male subjects and women of childbearing potential * complies with all required study procedures and restrictions
Exclusion criteria
* clinically significant medical history, current medical or psychiatric condition * clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline * current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1 * participation in any other investigational drug study within 90 days of screening * recent or current history of alcohol or drug abuse * regular recent use of tobacco or nicotine products * positive serology for HBV, HCV, or HIV * pregnant or nursing * donation or loss of greater than 400 mL of blood within the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule) | plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
| Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted) | lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period |
Secondary
| Measure | Time frame |
|---|---|
| laboratory analyses | absolute and change from baseline through end of study, approximately 35 days |
| vital signs | absolute and change from baseline through end of study, approximately 35 days |
| physical examination findings | absolute and change from baseline through end of study, approximately 35 days |
| electrocardiograms | absolute and change from baseline through end of study, approximately 35 days |
| adverse events | absolute and change from baseline through end of study, approximately 35 days |
Countries
United Kingdom
Outcome results
None listed