A Relative Bioavailability Study of Two Formulations of BCX7353

Phase 1

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: BCX7353

• Registration Number: NCT03202784
• Lead Sponsor: BioCryst Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Primary Completion: 2017-08-01
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BCX7353 blend in capsule	BCX7353	fasted administration of BCX7353 blend in capsule
BCX7353 API in capsule	BCX7353	fasted administration of BCX7353 API in capsule
BCX7353 blend in capsule with food	BCX7353	administration of BCX7353 blend in capsule following high-fat meal

Primary Outcome Measures

Name	Time	Method
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) 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 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

Name	Time	Method
laboratory analyses	absolute and change from baseline through end of study, approximately 35 days
adverse events	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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom