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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Fed Cohort PBT2
* Drug: Fasted Cohort PBT2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fed Cohort<br>PBT2 250 mg is administered orally following a high fat breakfast | Drug: Fed Cohort PBT2<br>* PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.<br>|
| Other: Fasted Cohort<br>PBT2 250 mg is administered orally following a 10 hour period of fasting | Drug: Fasted Cohort PBT2<br>* PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |