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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Caffeine Dosing

Single dose of caffeine 100 mg administered

Group Type OTHER

PBT2

Intervention Type DRUG

PBT2 250 mg administered

Interventions

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PBT2

PBT2 250 mg administered

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes