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

Hereditary Angioedema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218294
• Other study ID #: BCX4161-103
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2014
• Last updated: October 27, 2014
• Start date: August 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• BCX4161

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine		Determined from samples drawn up to 4 days post-dose	No
Secondary	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	No
Secondary	Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161		Data generated from samples drawn up to 7 days post-dose	No
Secondary	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	No