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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PBT2

• Registration Number: NCT02109497
• Lead Sponsor: Prana Biotechnology Limited

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.

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 Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Results First Submitted: 2015-11-17
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-29
• Last Update Submitted: 2016-03-29
• Results First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caffeine Dosing	PBT2	Single dose of caffeine 100 mg administered

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre for Clinical Studies - Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia