Back to resultsA Relative Bioavailability Study of Two Formulations of BCX7353
Primary Purpose
Hereditary Angioedema
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BCX7353
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Angioedema
Eligibility Criteria
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
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BCX7353 API in capsule
BCX7353 blend in capsule
BCX7353 blend in capsule with food
Arm Description
fasted administration of BCX7353 API in capsule
fasted administration of BCX7353 blend in capsule
administration of BCX7353 blend in capsule following high-fat meal
Outcomes
Primary Outcome Measures
Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule)
Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule)
Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule)
Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Secondary Outcome Measures
adverse events
laboratory analyses
vital signs
physical examination findings
electrocardiograms
Full Information
NCT ID
NCT03202784
First Posted
June 27, 2017
Last Updated
January 24, 2020
Sponsor
BioCryst Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03202784
Brief Title
A Relative Bioavailability Study of Two Formulations of BCX7353
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCX7353 API in capsule
Arm Type
Experimental
Arm Description
fasted administration of BCX7353 API in capsule
Arm Title
BCX7353 blend in capsule
Arm Type
Experimental
Arm Description
fasted administration of BCX7353 blend in capsule
Arm Title
BCX7353 blend in capsule with food
Arm Type
Experimental
Arm Description
administration of BCX7353 blend in capsule following high-fat meal
Intervention Type
Drug
Intervention Name(s)
BCX7353
Intervention Description
BCX7353
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
adverse events
Time Frame
absolute and change from baseline through end of study, approximately 35 days
Title
laboratory analyses
Time Frame
absolute and change from baseline through end of study, approximately 35 days
Title
vital signs
Time Frame
absolute and change from baseline through end of study, approximately 35 days
Title
physical examination findings
Time Frame
absolute and change from baseline through end of study, approximately 35 days
Title
electrocardiograms
Time Frame
absolute and change from baseline through end of study, approximately 35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Litza McKenzie, MBChB, BScMedSci
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Relative Bioavailability Study of Two Formulations of BCX7353
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