Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

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.

Arms:
arm 1: PBT2 250 mg is administered orally following a high fat breakfast arm 2: PBT2 250 mg is administered orally following a 10 hour period of fasting

Interventions: intervention 1: Fed Cohort PBT2 intervention 2: Fasted Cohort PBT2
Intervention descriptions: intervention 1: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. intervention 2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Protocol document: