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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02107313




Registration number
NCT02107313
Ethics application status
Date submitted
3/04/2014
Date registered
8/04/2014
Date last updated
30/03/2016

Titles & IDs
Public title
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Scientific title
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
Secondary ID [1] 0 0
PBT2-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fed Cohort PBT2
Treatment: Drugs - Fasted Cohort PBT2

Other: Fed Cohort - PBT2 250 mg is administered orally following a high fat breakfast

Other: Fasted Cohort - PBT2 250 mg is administered orally following a 10 hour period of fasting


Treatment: Drugs: Fed Cohort PBT2
PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.

Treatment: Drugs: Fasted Cohort PBT2
PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration-Time Curve (AUC 0-t)
Timepoint [1] 0 0
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 outcome [1] 0 0
Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events
Timepoint [1] 0 0
Up to 15 days after the first dose of PBT2

Eligibility
Key inclusion criteria
- Healthy male or females with a BMI between 19 and 30kg/m2

- No clinically significant abnormalities
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Clinical Studies - Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Prana Biotechnology Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02107313
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Caroline Herd
Address 0 0
Prana Biotechnology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications