A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

Phase 1

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: BCX4161

• Registration Number: NCT02125162
• Lead Sponsor: BioCryst Pharmaceuticals

Brief Summary

The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-29
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Written informed consent
• Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg
• Abide by study restrictions
• Attend all study visits
• Acceptable birth control measures

Key

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Exclusion Criteria

• Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
• Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits
• Pregnant or nursing
• Recent history of alcohol abuse or positive drugs of abuse screen
• Current smokers
• Donation or loss of greater than 400 mL of blood within 3 months

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment C	BCX4161	BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1
Treatment B	BCX4161	BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1
Treatment A	BCX4161	BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules	Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations	Screening through study completion (approximately 61 days)
Plasma pharmacokinetics to assess the effect of food on BCX4161	Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Ruddington, Nottingham, United Kingdom