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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Fasted Cohort PBT2; Drug: Fed Cohort PBT2

• Registration Number: NCT02107313
• Lead Sponsor: Prana Biotechnology Limited

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Results First Submitted: 2015-11-17
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-28
• Last Update Submitted: 2016-02-28
• Results First Posted: 2016-03-30
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasted Cohort	Fasted Cohort PBT2	PBT2 250 mg is administered orally following a 10 hour period of fasting
Fed Cohort	Fed Cohort PBT2	PBT2 250 mg is administered orally following a high fat breakfast

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre for Clinical Studies - Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia