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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Fed Cohort PBT2; Drug: Fasted Cohort PBT2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Centre for Clinical Studies - Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Fed Cohort; PBT2 250 mg is administered orally following a high fat breakfast	Drug: Fed Cohort PBT2; PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
OTHER: Fasted Cohort; PBT2 250 mg is administered orally following a 10 hour period of fasting	Drug: Fasted Cohort PBT2; PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-Time Curve (AUC 0-t)	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 Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events	Up to 15 days after the first dose of PBT2

Collaborators and Investigators

• Sponsor: Prana Biotechnology Limited
• Investigators: Study Director: Caroline Herd, Prana Biotechnology

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (ESTIMATE): April 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 30, 2016
• Last Update Submitted That Met QC Criteria: February 28, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PBT2-103