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Completed

NCT Number: NCT02107313

Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2

This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Clinical Studies - Nucleus Network

Melbourne, Victoria, 3004, Australia

About this study

The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or females with a BMI between 19 and 30kg/m2
  • No clinically significant abnormalities

Exclusion criteria

  • Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
  • Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
  • Significant history of depression or other psychiatric illness
  • Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
  • unable to swallow capsules

Treatment and study plan

Fed Cohort PBT2

Drug

PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.

Fasted Cohort PBT2

Drug

PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Primary outcomes

  1. Area Under the Concentration-Time Curve (AUC 0-t)

    Time frame: prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose

Secondary outcomes

  1. Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events

    Time frame: Up to 15 days after the first dose of PBT2

Sponsors and collaborators

Lead sponsor

Prana Biotechnology Limited

Industry

Registry information

Official study title

A Phase 1, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 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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