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Completed

NCT Number: NCT02109497

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Clinical Studies - Nucleus Network

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBT2

Drug

PBT2 250 mg administered

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg

    Time frame: 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.

    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.

Secondary outcomes

  1. Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event

    Time frame: Up to 19 days after first dose of caffeine

Sponsors and collaborators

Lead sponsor

Prana Biotechnology Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2014
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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