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

Primary Purpose

Hereditary Angioedema

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BCX4161

About this trial

This is an interventional treatment trial for Hereditary Angioedema focused on measuring BCX4161, BioCryst, hereditary angioedema, relative bioavailability, kallikrein inhibitor

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Key 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 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

Sites / Locations

Quotient Clinical Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules

Secondary Outcome Measures

Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations

Plasma pharmacokinetics to assess the effect of food on BCX4161

Full Information

NCT ID

NCT02125162

First Posted

April 24, 2014

Last Updated

August 14, 2014

Sponsor

BioCryst Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02125162

Brief Title

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

Official Title

A Single-dose, Randomized, 3-period, Crossover Study to Evaluate the Relative Bioavailability of BCX4161 Formulated as a Soft Gelatin Capsule to BCX4161 Formulated as a Hard Gelatin Capsule and the Effect of Food on BCX4161 Pharmacokinetics

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioCryst Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Angioedema

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment B

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment C

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BCX4161

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules

Time Frame

Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Secondary Outcome Measure Information:

Title

Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations

Time Frame

Screening through study completion (approximately 61 days)

Title

Plasma pharmacokinetics to assess the effect of food on BCX4161

Time Frame

Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanne Collier

Organizational Affiliation

Quotient Clinical Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quotient Clinical Ltd

City

Ruddington

State/Province

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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