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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Absolute Bioavailability

IV PBT2 microtracer and oral PBT2 single dose

Group Type EXPERIMENTAL

IV PBT2 microtracer and oral PBT2 single dose

Intervention Type DRUG

Radiolabelled AME

oral 14C PBT2

Group Type EXPERIMENTAL

oral 14C-PBT2

Intervention Type DRUG

Interventions

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IV PBT2 microtracer and oral PBT2 single dose

Intervention Type DRUG

oral 14C-PBT2

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes