Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
A Phase 1, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers
1 other identifier
interventional
18
1 country
1
Brief Summary
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started May 2014
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
March 30, 2016
CompletedMarch 30, 2016
February 1, 2016
1 month
April 3, 2014
November 17, 2015
February 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Concentration-Time Curve (AUC 0-t)
prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 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 Events
Up to 15 days after the first dose of PBT2
Study Arms (2)
Fed Cohort
OTHERPBT2 250 mg is administered orally following a high fat breakfast
Fasted Cohort
OTHERPBT2 250 mg is administered orally following a 10 hour period of fasting
Interventions
PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
Eligibility Criteria
You may qualify if:
- Healthy male 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 within 72 hours of study entry
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Studies - Nucleus Network
Melbourne, Victoria, 3004, Australia
Results Point of Contact
- Title
- Dr Caroline Herd
- Organization
- Prana Biotechnology
Study Officials
- STUDY DIRECTOR
Caroline Herd
Prana Biotechnology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2014
First Posted
April 8, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
March 30, 2016
Results First Posted
March 30, 2016
Record last verified: 2016-02