Clinical trial NCT03202784: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hereditary Angioedema
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule)
timeFrame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
measure: Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule)
timeFrame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
measure: Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule)
timeFrame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
measure: Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
timeFrame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
measure: Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
timeFrame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
measure: Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
timeFrame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Secondary outcomes:
measure: adverse events
timeFrame: absolute and change from baseline through end of study, approximately 35 days
measure: laboratory analyses
timeFrame: absolute and change from baseline through end of study, approximately 35 days
measure: vital signs
timeFrame: absolute and change from baseline through end of study, approximately 35 days
measure: physical examination findings
timeFrame: absolute and change from baseline through end of study, approximately 35 days
measure: electrocardiograms
timeFrame: absolute and change from baseline through end of study, approximately 35 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical
name: Litza McKenzie, MBChB, BScMedSci
role: PRINCIPAL_INVESTIGATOR
References: