A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

Study Overview
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Brief Summary
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The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.

Official Title
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A Single-dose, Randomized, 3-period, Crossover Study to Evaluate the Relative Bioavailability of BCX4161 Formulated as a Soft Gelatin Capsule to BCX4161 Formulated as a Hard Gelatin Capsule and the Effect of Food on BCX4161 Pharmacokinetics

Conditions
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Hereditary Angioedema

Intervention / Treatment
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* Drug: BCX4161


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Written informed consent Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg Abide by study restrictions Attend all study visits Acceptable birth control measures Key Exclusion Criteria: Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits Pregnant or nursing Recent history of alcohol abuse or positive drugs of abuse screen Current smokers Donation or loss of greater than 400 mL of blood within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1 | Drug: BCX4161<br>* Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose<br>|
| Experimental: Treatment B<br>BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1 | Drug: BCX4161<br>* Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose<br>|
| Experimental: Treatment C<br>BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1 | Drug: BCX4161<br>* Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules |  | Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations |  | Screening through study completion (approximately 61 days) | 
| Plasma pharmacokinetics to assess the effect of food on BCX4161 |  | Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCX4161, BioCryst, hereditary angioedema, relative bioavailability, kallikrein inhibitor