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

BioCryst Pharmaceuticals28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hereditary Angioedema

Interventions

BCX4161DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical Ltd

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules

Time frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Secondary Outcomes

Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations

Time frame: Screening through study completion (approximately 61 days)

Plasma pharmacokinetics to assess the effect of food on BCX4161

Time frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Data from ClinicalTrials.gov

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