A Relative Bioavailability Study of Two Formulations of BCX7353

January 24, 2020 updated by: BioCryst Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCX7353 API in capsule
fasted administration of BCX7353 API in capsule
Drug: BCX7353
BCX7353
Experimental: BCX7353 blend in capsule
fasted administration of BCX7353 blend in capsule
Drug: BCX7353
BCX7353
Experimental: BCX7353 blend in capsule with food
administration of BCX7353 blend in capsule following high-fat meal
Drug: BCX7353
BCX7353

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
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)
Time Frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
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)
Time Frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
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)
Time Frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
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)
Time Frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: absolute and change from baseline through end of study, approximately 35 days
absolute and change from baseline through end of study, approximately 35 days
laboratory analyses
Time Frame: absolute and change from baseline through end of study, approximately 35 days
absolute and change from baseline through end of study, approximately 35 days
vital signs
Time Frame: absolute and change from baseline through end of study, approximately 35 days
absolute and change from baseline through end of study, approximately 35 days
physical examination findings
Time Frame: absolute and change from baseline through end of study, approximately 35 days
absolute and change from baseline through end of study, approximately 35 days
electrocardiograms
Time Frame: absolute and change from baseline through end of study, approximately 35 days
absolute and change from baseline through end of study, approximately 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Investigators

  • Principal Investigator: Litza McKenzie, MBChB, BScMedSci, Quotient Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX7353-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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