Healthy VolunteerPhase 1NCT01543529
A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
A Phase 1 study testing RO4917838 and Alcohol in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4917838 and Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2012to 4 Jun 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy volunteers, 18 to 45 years, inclusive
- Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
- Non-smoker or smoker of fewer than 10 cigarettes per day
- Females, who are not menopausal must agree to use two adequate methods of contraception
Who cannot join
- Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
- History of alcoholism
- History of drug abuse and/or addiction within one year of study start
- History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers
This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917838, Placebo to RO4917838, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917838Drug
Single dose of RO4917838
Placebo to RO4917838Drug
Single dose of placebo to RO4917838
AlcoholOther
Standard alcoholic drink
| Study group | Role | What they receive |
|---|---|---|
| RO4917838 + non-alcoholic drink | Active comparator | Not described Receives: Drug: RO4917838 |
| RO4917838 + alcohol | Experimental | Not described Receives: Drug: RO4917838; Other: Alcohol |
| RO4917838 placebo + alcohol | Placebo comparator | Not described Receives: Drug: Placebo to RO4917838; Other: Alcohol |
| RO4917838 placebo + non-alcoholic drink | Placebo comparator | Not described Receives: Drug: Placebo to RO4917838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
Measured: Day 1 of each treatment period
Secondary outcomes (2)
Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838
Measured: Days 1, 2, 3, 4, 6, and 8 of each treatment period
Safety: Incidence of adverse events
Measured: Approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study start28 Feb 2012
- Primary completion4 Jun 2012
- Study completion4 Jun 2012
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 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
- NCT01543529
- Sponsor's protocol ID
- BP28180
- Status last verified
- May 2017
- First submitted
- 28 Feb 2012
- Last updated
- 10 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01543529
- Acronym / sponsor ID
- BP28180
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2012 (actual)
- Primary completion
- 4 Jun 2012 (actual)
- Study completion
- 4 Jun 2012 (actual)
- First posted
- 5 Mar 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, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RO4917838 + non-alcoholic drink | Active comparator | Drug: RO4917838 |
| RO4917838 + alcohol | Experimental | Drug: RO4917838, Other: Alcohol |
| RO4917838 placebo + alcohol | Placebo comparator | Drug: Placebo to RO4917838, Other: Alcohol |
| RO4917838 placebo + non-alcoholic drink | Placebo comparator | Drug: Placebo to RO4917838 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult healthy volunteers, 18 to 45 years, inclusive
- Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
- Non-smoker or smoker of fewer than 10 cigarettes per day
- Females, who are not menopausal must agree to use two adequate methods of contraception
Key exclusion criteria (4 listed)
- Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
- History of alcoholism
- History of drug abuse and/or addiction within one year of study start
- History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
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 |
|---|---|---|
| RO4917838Single dose of RO4917838 | Drug | RO4917838 + alcohol, RO4917838 + non-alcoholic drink |
| Placebo to RO4917838Single dose of placebo to RO4917838 | Drug | RO4917838 placebo + alcohol, RO4917838 placebo + non-alcoholic drink |
| AlcoholStandard alcoholic drink | Other | RO4917838 + alcohol, RO4917838 placebo + alcohol |
Primary outcome
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
Time frame: Day 1 of each treatment period
2 secondary outcomes
Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838
Time frame: Days 1, 2, 3, 4, 6, and 8 of each treatment period
Safety: Incidence of adverse events
Time frame: Approximately 4 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 10 May 2017.
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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
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 RO4917838 and Alcohol 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 4 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 10 May 2017. 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?
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838 (time frame: Day 1 of each treatment period). 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 10 May 2017.