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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
18
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02107313