Healthy VolunteerPhase 1NCT01708616
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
A Phase 1 study testing RO5285119 and risperidone in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO5285119 and risperidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Women have to be postmenopausal or surgically sterile
- Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing
Who cannot join
- Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- History of clinically significant hypersensitivity or allergic reactions
- Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
- Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
- Administration of an investigational drug or device within 3 months prior to first dosing
- Hypersensitivity to risperidone or any of its excipients
- Any other known contraindications to risperidone as stated in the SmPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects
This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).
- Conditions
- Healthy Volunteer
- Being tested
- RO5285119, RO5285119 placebo, risperidone, risperidone placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5285119Drug
multiple doses
RO5285119 placeboDrug
multiple doses
risperidoneDrug
single dose
risperidone placeboDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo + risperidone | Placebo comparator | Not described Receives: Drug: RO5285119 placebo; Drug: risperidone |
| Placebo +placebo | Placebo comparator | Not described Receives: Drug: RO5285119 placebo; Drug: risperidone placebo |
| RO5285119 + placebo | Active comparator | Not described Receives: Drug: RO5285119; Drug: risperidone placebo |
| RO5285119 + risperidone | Experimental | Not described Receives: Drug: RO5285119; Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)
Measured: Pre-dose to 24 hours post-dose
Secondary outcomes (5)
Safety: Incidence of adverse events
Measured: approximately 12 weeks
Pharmacodynamic markers for risperidone: Prolactin levels
Measured: Pre-dose to 6 hours post-dose
Pharmacodynamic assessments for risperidone: Level of sedation
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
Measured: Day 1 to Day 18
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
Measured: Day1 to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 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
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01708616
- Sponsor's protocol ID
- BP28318
- Other IDs
- 2012-003231-31
- Status last verified
- Nov 2016
- First submitted
- 15 Oct 2012
- 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-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01708616
- Acronym / sponsor ID
- BP28318
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Oct 2012 (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, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).
Study design
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo + risperidone | Placebo comparator | Drug: RO5285119 placebo, Drug: risperidone |
| Placebo +placebo | Placebo comparator | Drug: RO5285119 placebo, Drug: risperidone placebo |
| RO5285119 + placebo | Active comparator | Drug: RO5285119, Drug: risperidone placebo |
| RO5285119 + risperidone | Experimental | Drug: RO5285119, Drug: risperidone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Women have to be postmenopausal or surgically sterile
- Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing
Key exclusion criteria (8 listed)
- Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- History of clinically significant hypersensitivity or allergic reactions
- Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
- Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
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 |
|---|---|---|
| RO5285119multiple doses | Drug | RO5285119 + placebo, RO5285119 + risperidone |
| RO5285119 placebomultiple doses | Drug | Placebo + risperidone, Placebo +placebo |
| risperidonesingle dose | Drug | Placebo + risperidone, RO5285119 + risperidone |
| risperidone placebosingle dose | Drug | Placebo +placebo, RO5285119 + placebo |
Primary outcome
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)
Time frame: Pre-dose to 24 hours post-dose
5 secondary outcomes
Safety: Incidence of adverse events
Time frame: approximately 12 weeks
Pharmacodynamic markers for risperidone: Prolactin levels
Time frame: Pre-dose to 6 hours post-dose
Pharmacodynamic assessments for risperidone: Level of sedation
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 18
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
Time frame: Day1 to Day 18
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 RO5285119 and risperidone in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
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 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 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 France. 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax) (time frame: Pre-dose to 24 hours post-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 2 Nov 2016.