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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PBT2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Centre for Clinical Studies - Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Caffeine Dosing; Single dose of caffeine 100 mg administered	Drug: PBT2; PBT2 250 mg administered

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Prana Biotechnology Limited
• Investigators: Study Director: Caroline Herd, Prana Biotechnology

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (ESTIMATE): April 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PBT2-104