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

Prana Biotechnology Limited6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

IV PBT2 microtracer and oral PBT2 single doseDRUG

oral 14C-PBT2DRUG

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical

Nottingham, Nottinghamshire, United Kingdom

Outcomes

Primary Outcomes

Absolute Bioavailability of PBT2 (F%)

Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).

Time frame: 0 to 72 hours post oral dose

Mass Balance

Amount excreted as a percentage of the administered dose (%Ae)

Time frame: 168 h (7 days) post dose

Secondary Outcomes

IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)

Area under the plasma concentration vs time curve from time 0h to the last time point of IV \[14C\]-PBT2 .

Time frame: 0 to 72 h post oral dose

Oral PK Profile of PBT2 as Assessed by AUC(0-last)

Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .

Time frame: 72 h post oral dose

Safety and Tolerability of PBT2

As assessed by the number of participants with adverse events

Time frame: 72 h post oral dose

Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours

Ratio of whole blood, plasma \[14C\] PBT2 at 24 hours

Time frame: 0 to 24 hours

Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)

area under the plasma concentration vs time curve to the last timepoint

Time frame: 0 to 72 hours

Data from ClinicalTrials.gov

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