Status:
COMPLETED
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Lead Sponsor:
Prana Biotechnology Limited
Conditions:
Healthy Volunteers
Eligibility:
MALE
30-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelle...
Eligibility Criteria
Inclusion
- Healthy males
- Body mass index of 18.0 to 35.0 kg/m2
Exclusion
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02249728
Start Date
June 1 2014
End Date
July 1 2014
Last Update
March 30 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical
Nottingham, Nottinghamshire, United Kingdom, NG11 6JS