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

Prana Biotechnology

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: IV PBT2 microtracer and oral PBT2 single dose

Drug: oral 14C-PBT2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02249728

2014-000389-24 (EudraCT Number)

PBT2-102

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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