NCT02107313

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Prana Biotechnology Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Fed Cohort PBT2	PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
DRUG	Fasted Cohort PBT2	PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-04-08
• Last updated: 2016-03-30
• Results posted: 2016-03-30

Locations

1 site across 1 country: Australia