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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02125162

Enrollment

Registered

2014-04-29

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Keywords

BCX4161, BioCryst, hereditary angioedema, relative bioavailability, kallikrein inhibitor

Brief summary

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.

Interventions

DRUGBCX4161

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026