A Relative Bioavailability Study of Two Formulations of BCX7353

Phase 1CompletedNCT03202784

BioCryst Pharmaceuticals24 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hereditary Angioedema

Interventions

BCX7353DRUG

BCX7353

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Quotient Clinical

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

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

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

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

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

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

adverse events

Time frame: 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

Data from ClinicalTrials.gov

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