Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

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 radiolabelled intravenous injection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prana Biotechnology Limited

Criteria

Inclusion Criteria:

• Healthy males

• Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria:

• 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