A Relative Bioavailability Study of Two Formulations of BCX7353

BioCryst

Status and phase: Completed; Phase 1

Conditions: Hereditary Angioedema

Treatments: Drug: BCX7353

Study type: Interventional

Funder types: Industry

Identifiers

NCT03202784

BCX7353-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

BCX7353 API in capsule

Experimental group

Description:

fasted administration of BCX7353 API in capsule

Treatment:

Drug: BCX7353

BCX7353 blend in capsule

Experimental group

Description:

fasted administration of BCX7353 blend in capsule

Treatment:

Drug: BCX7353

BCX7353 blend in capsule with food

Experimental group

Description:

administration of BCX7353 blend in capsule following high-fat meal

Treatment:

Drug: BCX7353