Healthy VolunteersPhase 1NCT02107313

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

A Phase 1 study testing Fed Cohort PBT2 and Fasted Cohort PBT2 in people with Healthy Volunteers, run by Prana Biotechnology Limited at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Fed Cohort PBT2 and Fasted Cohort PBT2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteAustralia
Study dates: May 2014to Jul 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or females with a BMI between 19 and 30kg/m2
No clinically significant abnormalities

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Centre for Clinical Studies - Nucleus Network
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Conditions: Healthy Volunteers
Being tested: Fed Cohort PBT2, Fasted Cohort PBT2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fed Cohort PBT2Drug
PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
Fasted Cohort PBT2Drug
PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Study groups in NCT02107313
Study group	Role	What they receive
Fed Cohort	Other	PBT2 250 mg is administered orally following a high fat breakfast Receives: Drug: Fed Cohort PBT2
Fasted Cohort	Other	PBT2 250 mg is administered orally following a 10 hour period of fasting Receives: Drug: Fasted Cohort PBT2

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-Time Curve (AUC 0-t)
Measured: 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
Measured: Up to 15 days after the first dose of PBT2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jul 2014

First posted8 Apr 2014 (estimated)
Study startMay 2014
Primary completionJun 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107313
Sponsor's protocol ID: PBT2-103
Status last verified: Feb 2016
First submitted: 3 Apr 2014
Last updated: 30 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02107313
Acronym / sponsor ID: PBT2-103
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Prana Biotechnology LimitedIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Jun 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 30 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fed Cohort	Other	Drug: Fed Cohort PBT2PBT2 250 mg is administered orally following a high fat breakfast
Fasted Cohort	Other	Drug: Fasted Cohort PBT2PBT2 250 mg is administered orally following a 10 hour period of fasting

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male or females with a BMI between 19 and 30kg/m2
No clinically significant abnormalities

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fed Cohort PBT2PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.	Drug	Fed Cohort
Fasted Cohort PBT2PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food	Drug	Fasted Cohort

Primary outcome

Area Under the Concentration-Time Curve (AUC 0-t)
Time frame: 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

1 secondary outcome

Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events
Time frame: Up to 15 days after the first dose of PBT2

Results and safety

Results posted to the registry on 30 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fed Cohort First Then Fasted Cohort	9	9
Fasted Cohort First Then Fed Cohort	9	8

Primary outcome: Area Under the Concentration-Time Curve (AUC 0-t)

Time frame: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Fed Cohort n = 18	Fasted Cohort n = 17
Value	1490.0 (542.0)	1273.0 (552.3)

Population analysed: PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fed Cohort	0 of 17 (0%)	6 of 17 (35.3%)	Not reported
Fasted Cohort	0 of 18 (0%)	2 of 18 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caroline Herd study director

Prana Biotechnology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fed Cohort PBT2 and Fasted Cohort PBT2 in people with Healthy Volunteers, run by Prana Biotechnology Limited at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve (AUC 0-t) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.