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Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

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, mass balance, kallikrein inhibitor, ADME

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males
Age 30 to 65 years of age (inclusive)
Body mass index of 18.0 to 32.0 kg/m2
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent
A history of regular bowel movements
Must agree to use an adequate method of contraception

Key Exclusion Criteria:

Participation in a clinical research study within the previous 3 months
Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen
Current smokers
Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
Activated partial thromboplastin time or PT outside of normal laboratory limits

Sites / Locations

Quotient Clinical Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[14C] BCX4161

Arm Description

Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161

Outcomes

Primary Outcome Measures

Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces

Secondary Outcome Measures

Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine

Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161

Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161

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

Full Information

NCT ID

NCT02218294

First Posted

August 14, 2014

Last Updated

October 27, 2014

Sponsor

BioCryst Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02218294

Brief Title

Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

Official Title

A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 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 assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.

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, mass balance, kallikrein inhibitor, ADME

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

[14C] BCX4161

Arm Type

Experimental

Arm Description

Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161

Intervention Type

Drug

Intervention Name(s)

BCX4161

Primary Outcome Measure Information:

Title

Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces

Time Frame

Determined from samples drawn up to 14 days post-dose

Secondary Outcome Measure Information:

Title

Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine

Time Frame

Determined from samples drawn up to 4 days post-dose

Title

Time Frame

Data generated from samples drawn up to 7 days post-dose

Title

Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161

Time Frame

Data generated from samples drawn up to 7 days post-dose

Title

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

Time Frame

Over the duration of the study, approximately 6 weeks from screening through follow-up

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males Age 30 to 65 years of age (inclusive) Body mass index of 18.0 to 32.0 kg/m2 Must be willing and able to communicate and participate in the whole study Must provide written informed consent A history of regular bowel movements Must agree to use an adequate method of contraception Key Exclusion Criteria: Participation in a clinical research study within the previous 3 months Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen Current smokers Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality Activated partial thromboplastin time or PT outside of normal laboratory limits

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanne Collier, MBChB, FFPM, Dip Stats (OU)

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

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Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

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