Healthy VolunteerPhase 1NCT01665976
A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers
A Phase 1 study testing RO4917838 and RO4927838 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4917838 and RO4927838
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Nov 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers, 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
- Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
- Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug
Who cannot join
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
- History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period 1. Day -1 of the study
- History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
- Any history of depressive episodes or treatment with antidepressants
- Any significant allergic reactions against any drug, or multiple allergies in the judgement of the Investigator
- Pregnant or lactating females
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in another investigational study of any type within 90 days of RO4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food Following Oral Administration in Healthy Subjects
This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917838, RO4927838
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917838Drug
film coated tablet, single dose
RO4917838Drug
oral suspension, single dose
RO4927838Drug
hard gelatin capsule, single dose
| Study group | Role | What they receive |
|---|---|---|
| A: film coated tablets, fasted condition | Experimental | Not described Receives: Drug: RO4917838 |
| B: film coated tablets, fed condition | Experimental | Not described Receives: Drug: RO4917838 |
| C: hard gelatin capsules | Experimental | Not described Receives: Drug: RO4927838 |
| D: oral suspension | Experimental | Not described Receives: Drug: RO4917838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01665976
- Sponsor's protocol ID
- BP25593
- Other IDs
- 2012-000739-13
- Status last verified
- Nov 2016
- First submitted
- 14 Aug 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, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food Following Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01665976
- Acronym / sponsor ID
- BP25593
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Aug 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, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: film coated tablets, fasted condition | Experimental | Drug: RO4917838 |
| B: film coated tablets, fed condition | Experimental | Drug: RO4917838 |
| C: hard gelatin capsules | Experimental | Drug: RO4927838 |
| D: oral suspension | Experimental | Drug: RO4917838 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male and female volunteers, 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
- Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
- Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug
Key exclusion criteria (8 listed)
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
- History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period 1. Day -1 of the study
- History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
- Any history of depressive episodes or treatment with antidepressants
- Any significant allergic reactions against any drug, or multiple allergies in the judgement of 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 |
|---|---|---|
| RO4917838film coated tablet, single dose | Drug | A: film coated tablets, fasted condition, B: film coated tablets, fed condition |
| RO4917838oral suspension, single dose | Drug | D: oral suspension |
| RO4927838hard gelatin capsule, single dose | Drug | C: hard gelatin capsules |
Primary outcome
Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
1 secondary outcome
Safety: Incidence of adverse events
Time frame: approximately 2 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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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 RO4927838 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 5 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. 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 high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC) (time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12). The study lists 3 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; AzTrials last refreshed its copy on 7 Nov 2026.