Healthy VolunteersPhase 1NCT02249728
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
A Phase 1 study testing IV PBT2 microtracer and oral PBT2 single dose and oral 14C-PBT2 in people with Healthy Volunteers, run by Prana Biotechnology Limited at 1 site in United Kingdom.
Trial summary
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IV PBT2 microtracer and oral PBT2 single dose and oral 14C-PBT2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Body mass index of 18.0 to 35.0 kg/m2
Who cannot join
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.
- Conditions
- Healthy Volunteers
- Being tested
- IV PBT2 microtracer and oral PBT2 single dose, oral 14C-PBT2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV PBT2 microtracer and oral PBT2 single doseDrug
oral 14C-PBT2Drug
| Study group | Role | What they receive |
|---|---|---|
| Absolute Bioavailability | Experimental | IV PBT2 microtracer and oral PBT2 single dose Receives: Drug: IV PBT2 microtracer and oral PBT2 single dose |
| Radiolabelled AME | Experimental | oral 14C PBT2 Receives: Drug: oral 14C-PBT2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability of PBT2 (F%)
Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).
Measured: 0 to 72 hours post oral dose
Mass Balance
Amount excreted as a percentage of the administered dose (%Ae)
Measured: 168 h (7 days) post dose
Secondary outcomes (5)
IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)
Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .
Measured: 0 to 72 h post oral dose
Oral PK Profile of PBT2 as Assessed by AUC(0-last)
Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .
Measured: 72 h post oral dose
Safety and Tolerability of PBT2
As assessed by the number of participants with adverse events
Measured: 72 h post oral dose
Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours
Ratio of whole blood, plasma [14C] PBT2 at 24 hours
Measured: 0 to 24 hours
Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)
area under the plasma concentration vs time curve to the last timepoint
Measured: 0 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionJul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prana Biotechnology Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Herd, PhD, Study director, Prana Biotechnology Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249728
- Sponsor's protocol ID
- PBT2-102
- Other IDs
- 2014-000389-24, 2014
- Status last verified
- Feb 2016
- First submitted
- 30 Jul 2014
- Last updated
- 30 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02249728
- Acronym / sponsor ID
- PBT2-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Prana Biotechnology LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Sep 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.
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute Bioavailability | Experimental | Drug: IV PBT2 microtracer and oral PBT2 single doseIV PBT2 microtracer and oral PBT2 single dose |
| Radiolabelled AME | Experimental | Drug: oral 14C-PBT2oral 14C PBT2 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males
- Body mass index of 18.0 to 35.0 kg/m2
Key exclusion criteria (8 listed)
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
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 |
|---|---|---|
| IV PBT2 microtracer and oral PBT2 single dose | Drug | Absolute Bioavailability |
| oral 14C-PBT2 | Drug | Radiolabelled AME |
Primary outcome
Absolute Bioavailability of PBT2 (F%)
Time frame: 0 to 72 hours post oral dose
Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).
Mass Balance
Time frame: 168 h (7 days) post dose
Amount excreted as a percentage of the administered dose (%Ae)
5 secondary outcomes
IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)
Time frame: 0 to 72 h post oral dose
Oral PK Profile of PBT2 as Assessed by AUC(0-last)
Time frame: 72 h post oral dose
Safety and Tolerability of PBT2
Time frame: 72 h post oral dose
Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours
Time frame: 0 to 24 hours
Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)
Time frame: 0 to 72 hours
Results and safety
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.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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, PhD study director
Prana Biotechnology Ltd
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 IV PBT2 microtracer and oral PBT2 single dose and oral 14C-PBT2 in people with Healthy Volunteers, run by Prana Biotechnology Limited at 1 site in United Kingdom.
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 8 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 United Kingdom. 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?
Absolute Bioavailability of PBT2 (F%) (time frame: 0 to 72 hours post oral dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.