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

Phase 1

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: BCX4161

• Registration Number: NCT02218294
• Lead Sponsor: BioCryst Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

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

Key

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] BCX4161	BCX4161	Includes a radiolabelled dose of \[14C\] BCX4161 and unlabelled BCX4161

Primary Outcome Measures

Name	Time	Method
Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces	Determined from samples drawn up to 14 days post-dose

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations	Over the duration of the study, approximately 6 weeks from screening through follow-up
Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine	Determined from samples drawn up to 4 days post-dose
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	Data generated from samples drawn up to 7 days post-dose
Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161	Data generated from samples drawn up to 7 days post-dose

Trial Locations

Locations (1)

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