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Completed

NCT Number: NCT03202784

A Relative Bioavailability Study of Two Formulations of BCX7353

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCX7353

Drug

BCX7353

Primary outcomes

  1. Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule)

    Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

  2. Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule)

    Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

  3. Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule)

    Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

  4. Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)

    Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

  5. Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)

    Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

  6. Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)

    Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

Secondary outcomes

  1. adverse events

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

  2. laboratory analyses

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

  3. vital signs

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

  4. physical examination findings

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

  5. electrocardiograms

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

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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