A Relative Bioavailability Study of Two Formulations of BCX7353

Hereditary Angioedema Clinical Trial

Official title:

A Phase 1, Single-Dose, 3-Period Crossover Study to Evaluate the Relative Bioavailability of Two BCX7353 Capsule Formulations and to Evaluate the Effect of Food on BCX7353 Pharmacokinetics in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202784
• Other study ID #: BCX7353-103
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• BCX7353
BCX7353

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	adverse events		absolute and change from baseline through end of study, approximately 35 days
Secondary	laboratory analyses		absolute and change from baseline through end of study, approximately 35 days
Secondary	vital signs		absolute and change from baseline through end of study, approximately 35 days
Secondary	physical examination findings		absolute and change from baseline through end of study, approximately 35 days
Secondary	electrocardiograms		absolute and change from baseline through end of study, approximately 35 days