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

NCT02125162 | Completed Phase 1

• 1 other identifier: BCX4161-104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Angioedema

Keywords

BCX4161; BioCryst; hereditary angioedema; relative bioavailability; kallikrein inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1

Drug: BCX4161

Treatment B

EXPERIMENTAL

BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1

Drug: BCX4161

Treatment C

EXPERIMENTAL

BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1

Drug: BCX4161

Interventions

BCX4161 DRUG

Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (1)

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

avoralstat

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Joanne Collier

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

GB (1)