Healthy VolunteerPhase 1NCT01483469
A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers
A Phase 1 study testing RO4917523 and RO5011232 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.
Trial summary
This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4917523 and RO5011232
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers as determined by medical history, physical examination, 12-lead ECG, and routine clinical laboratory measurements
- Age 18 to 65 years inclusive
- Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg
- Appropriate body size (less than 195 cm [6 feet and 5 inches]) in order to accommodate the whole body scanning
Who cannot join
- History of or presence of clinically significant psychiatric condition, as evaluated by a psychiatrist before enrolment
- History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition or a history of migraine headaches
- Contraindications to MRI procedures (Part I, III and IV)
- Subjects suffering from claustrophobia or who would be unable to undergo magnetic resonance imaging (MRI) or PET scanning
- Positive pregnancy test at screening or on any day preceding a PET scan
- Lactating women
Show all 10Show fewer
- Positive for hepatitis B, hepatitis C or HIV infection
- Any history of alcohol or drug abuse within the last 6 months
- Regular smoker or nicotine user (>10 cigarettes per day)
- Participation in an investigational drug or device study within three months prior to screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baltimore, Maryland, 21224
Study site
Baltimore, Maryland, 21225
About this study
Official title: Human Proof of Concept Positron Emission Tomography Study to Investigate [11C]-RO5011232 as a Radiotracer for Brain mGlu5 Receptor Occupancy and to Investigate the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-state.
This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is up to 4 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917523, RO5011232
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917523Drug
orally daily, 14 days
RO5011232Drug
[11C]-RO5011232 intravenously
| Study group | Role | What they receive |
|---|---|---|
| Concept Proof | Active comparator | Not described Receives: Drug: RO5011232 |
| Receptor Occupancy | Experimental | Not described Receives: Drug: RO4917523; Drug: RO5011232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET)
Measured: approximately 6 months
Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan
Measured: approximately 6 months
Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain
Measured: approximately 6 months
Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain
Measured: approximately 6 months
Secondary outcomes (3)
Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events
Measured: approximately 6 months
Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET
Measured: approximately 6 months
Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT01483469
- Sponsor's protocol ID
- BP27890
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2011
- 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
- Human Proof of Concept Positron Emission Tomography Study to Investigate [11C]-RO5011232 as a Radiotracer for Brain mGlu5 Receptor Occupancy and to Investigate the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-state.
- ClinicalTrials.gov ID
- NCT01483469
- Acronym / sponsor ID
- BP27890
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Dec 2011 (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 open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is up to 4 weeks.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concept Proof | Active comparator | Drug: RO5011232 |
| Receptor Occupancy | Experimental | Drug: RO4917523, Drug: RO5011232 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers as determined by medical history, physical examination, 12-lead ECG, and routine clinical laboratory measurements
- Age 18 to 65 years inclusive
- Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg
- Appropriate body size (less than 195 cm [6 feet and 5 inches]) in order to accommodate the whole body scanning
Key exclusion criteria (10 listed)
- History of or presence of clinically significant psychiatric condition, as evaluated by a psychiatrist before enrolment
- History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition or a history of migraine headaches
- Contraindications to MRI procedures (Part I, III and IV)
- Subjects suffering from claustrophobia or who would be unable to undergo magnetic resonance imaging (MRI) or PET scanning
- Positive pregnancy test at screening or on any day preceding a PET scan
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 |
|---|---|---|
| RO4917523orally daily, 14 days | Drug | Receptor Occupancy |
| RO5011232[11C]-RO5011232 intravenously | Drug | Concept Proof, Receptor Occupancy |
Primary outcome
Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET)
Time frame: approximately 6 months
Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan
Time frame: approximately 6 months
Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain
Time frame: approximately 6 months
Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain
Time frame: approximately 6 months
3 secondary outcomes
Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events
Time frame: approximately 6 months
Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET
Time frame: approximately 6 months
Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events
Time frame: approximately 6 months
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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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.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO4917523 and RO5011232 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.
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 4 inclusion and 10 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 2 sites in United States. 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?
Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET) (time frame: approximately 6 months). The study lists 4 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.