A Relative Bioavailability Study of Two Formulations of BCX7353

NCT03202784 | Completed Phase 1

• 1 other identifier: BCX7353-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Hereditary Angioedema

Outcome Measures

Primary Outcomes (6)

• 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 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 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 Outcomes (5)

• adverse events

  absolute and change from baseline through end of study, approximately 35 days

• laboratory analyses

  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

Study Arms (3)

BCX7353 API in capsule

EXPERIMENTAL

fasted administration of BCX7353 API in capsule

Drug: BCX7353

BCX7353 blend in capsule

EXPERIMENTAL

fasted administration of BCX7353 blend in capsule

Drug: BCX7353

BCX7353 blend in capsule with food

EXPERIMENTAL

administration of BCX7353 blend in capsule following high-fat meal

Drug: BCX7353

Interventions

BCX7353 DRUG

BCX7353

BCX7353 API in capsule; BCX7353 blend in capsule; BCX7353 blend in capsule with food

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent
• acceptable birth control measures for male subjects and women of childbearing potential
• complies with all required study procedures and restrictions

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

berotralstat

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Litza McKenzie, MBChB, BScMedSci

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: February 27, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 30, 2017
• Last Updated: January 27, 2020

Record last verified: 2017-10

Locations

GB (1)