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

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 caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.

Detailed Description
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This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.

Official Title
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A Phase 1, Single Centre, Open Label, Two-period Study in Healthy Volunteers to Determine the Effect of PBT2 on the Pharmacokinetics of Caffeine

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PBT2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males 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 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 or tablets

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Caffeine Dosing<br>Single dose of caffeine 100 mg administered | Drug: PBT2<br>* PBT2 250 mg administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg | PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12. | prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 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 Event |  | Up to 19 days after first dose of caffeine |