Status:
COMPLETED
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema
Eligibility:
MALE
30-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02218294
Start Date
August 1 2014
End Date
September 1 2014
Last Update
October 29 2014
Active Locations (1)
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1
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom, NG11 6JS