A Relative Bioavailability Study of Two Formulations of BCX7353

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Single-Dose, 3-Period Crossover Study to Evaluate the Relative Bioavailability of Two BCX7353 Capsule Formulations and to Evaluate the Effect of Food on BCX7353 Pharmacokinetics in Healthy Subjects

Conditions
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Hereditary Angioedema

Intervention / Treatment
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* Drug: BCX7353


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCX7353 API in capsule<br>fasted administration of BCX7353 API in capsule | Drug: BCX7353<br>* BCX7353<br>|
| Experimental: BCX7353 blend in capsule<br>fasted administration of BCX7353 blend in capsule | Drug: BCX7353<br>* BCX7353<br>|
| Experimental: BCX7353 blend in capsule with food<br>administration of BCX7353 blend in capsule following high-fat meal | Drug: BCX7353<br>* BCX7353<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | absolute and change from baseline through end of study, approximately 35 days | 
| 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 |