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Completed

NCT Number: NCT02249728

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

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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Key information

Conditions

Healthy Volunteers

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV PBT2 microtracer and oral PBT2 single dose

Drug

oral 14C-PBT2

Drug

Primary outcomes

  1. Absolute Bioavailability of PBT2 (F%)

    Time frame: 0 to 72 hours post oral dose

    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).

  2. Mass Balance

    Time frame: 168 h (7 days) post dose

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

Secondary outcomes

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

    Time frame: 0 to 72 h post oral dose

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

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

    Time frame: 72 h post oral dose

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

  3. Safety and Tolerability of PBT2

    Time frame: 72 h post oral dose

    As assessed by the number of participants with adverse events

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

    Time frame: 0 to 24 hours

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

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

    Time frame: 0 to 72 hours

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

Sponsors and collaborators

Lead sponsor

Prana Biotechnology Limited

Industry

Registry information

Official study title

A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2014
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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