SchizophreniaPhase 1NCT01923025
A PET Study With RO5545965 in Healthy Male Volunteers
A Phase 1 study testing RO5545965 in people with Schizophrenia, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET). Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- RO5545965
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
- History of clinically significant hypersensitivity or allergic drug reactions
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- Positive for hepatitis B, hepatitis C, or HIV infection
- Evidence of significant cardiovascular disease or disorder
Show all 12Show fewer
- Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer
- Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities
- Subject has any condition that would prevent an MRI from accurately or safely being performed [eg, claustrophobia, cardiac pacemaker, metallic implants or clips]
- Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes
- Contraindication for arterial cannulation
- Unsuitable veins for repeated venipuncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography
This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).
- Conditions
- Schizophrenia
- Being tested
- RO5545965
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5545965Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| RO5545965 | Experimental | Not described Receives: Drug: RO5545965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Brain PDE10 occupancy by RO5545965
Measured: up to Day 2
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations
Measured: up to Day 2
Secondary outcomes (2)
Safety: Incidence of adverse events
Measured: up to 12 days
Pharmacokinetics: Plasma concentrations of RO5545965
Measured: up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923025
- Sponsor's protocol ID
- BP28844
- Other IDs
- 2013-000538-36
- Status last verified
- Nov 2016
- First submitted
- 8 Aug 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT01923025
- Acronym / sponsor ID
- BP28844
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RO5545965 | Experimental | Drug: RO5545965 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose
Key exclusion criteria (12 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
- History of clinically significant hypersensitivity or allergic drug reactions
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- Positive for hepatitis B, hepatitis C, or HIV infection
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 |
|---|---|---|
| RO5545965Single dose | Drug | RO5545965 |
Primary outcome
Pharmacodynamics: Brain PDE10 occupancy by RO5545965
Time frame: up to Day 2
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations
Time frame: up to Day 2
2 secondary outcomes
Safety: Incidence of adverse events
Time frame: up to 12 days
Pharmacokinetics: Plasma concentrations of RO5545965
Time frame: up to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 RO5545965 in people with Schizophrenia, run by Hoffmann-La Roche 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 3 inclusion and 12 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 2 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacodynamics: Brain PDE10 occupancy by RO5545965 (time frame: up to Day 2). 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 2 Nov 2016.