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

Prana Biotechnology

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Fasted Cohort PBT2

Drug: Fed Cohort PBT2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02107313

PBT2-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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