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

BioCryst

Status and phase: Completed; Phase 1

Conditions: Hereditary Angioedema

Treatments: Drug: BCX4161

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125162

BCX4161-104

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Treatment A

Experimental group

Description:

BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1

Treatment:

Drug: BCX4161

Treatment B

Experimental group

Description:

BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1

Treatment:

Drug: BCX4161

Treatment C

Experimental group

Description:

BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1

Treatment:

Drug: BCX4161