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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109497
• Other study ID #: PBT2-104
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2014
• Last updated: July 30, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Prana Biotechnology Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be conducted in 2 dosing periods with all participants receiving a dose of caffeine 100 mg in Period 1 followed by a 7 day washout period before receiving a further single dose of caffeine 100 mg after 5 consecutive days of receiving PBT2 250 mg . Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PBT2
PBT2 250 mg administered

Locations

Country	Name	City	State
Australia	Centre for Clinical Studies - Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Prana Biotechnology Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of caffeine after a dose of PBT2 250mg		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.	No
Secondary	Number of participants with serious and non-serious adverse events		Up to 19 days after first dose of caffeine	Yes