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

NCT02109497 | Completed Phase 1 Results

• 1 other identifier: PBT2-104
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Caffeine Dosing

OTHER

Single dose of caffeine 100 mg administered

Drug: PBT2

Interventions

PBT2 DRUG

PBT2 250 mg administered

Caffeine Dosing

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females with a BMI between 19 and 30kg/m2
• No clinically significant abnormalities

You may not qualify if:

• 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

Sponsors & Collaborators

• Prana Biotechnology Limited: lead

Study Sites (1)

Centre for Clinical Studies - Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Results Point of Contact

• Title: Dr Caroline Herd
• Organization: Prana Biotechnology

info@pranabio.com

+6133494906

Study Officials

• Caroline Herd

  Prana Biotechnology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 29, 2016
• Results First Posted: April 29, 2016

Record last verified: 2016-03

Locations

AU (1)