A Relative Bioavailability Study of Two Formulations of BCX7353

NCT03202784 — Phase 1, Completed, 24 participants, BioCryst Pharmaceuticals

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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

Registry	NCT03202784
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	BioCryst Pharmaceuticals (Industry)
Conditions	Hereditary Angioedema
Interventions	BCX7353 (Drug)
Dates	start 2017-02-27, primary completion 2017-08-01, completion 2017-09-30, first posted 2017-06-29, last updated 2020-01-27
Locations	1 site in United Kingdom

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
BCX7353 API in capsule	Experimental	Drug: BCX7353	fasted administration of BCX7353 API in capsule
BCX7353 blend in capsule	Experimental	Drug: BCX7353	fasted administration of BCX7353 blend in capsule
BCX7353 blend in capsule with food	Experimental	Drug: BCX7353	administration of BCX7353 blend in capsule following high-fat meal

BCX7353 (Drug): BCX7353

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Quotient Clinical	Nottingham	United Kingdom

+Investigators

Litza McKenzie, MBChB, BScMedSci, Principal investigator, Quotient Clinical