Healthy VolunteerPhase 1NCT01901159
A Study of RO4995819 to Assess Bioavailability and Safety in Healthy Volunteers
A Phase 1 study testing RO4995819 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in France.
Trial summary
This randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions. 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?
- RO4995819
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smoking male and female volunteers, 18 to 65 years of age, inclusive.
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
- Willing not to participate in any other clinical trial with an investigational drug or device for at least 3 months following the follow up visit.
- Male volunteers and their partners of childbearing potential must use two adequate methods of contraception. Female volunteers who are not either surgically sterile or postmenopausal must commit to use two adequate methods of contraception throughout the study and until at least 5 months after last dosing.
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder or cancer
- Significant past or present disorders of the central nervous system, psychiatric disorders, behavioral disturbances
- Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
- Any condition or disease detected during the medical interview / physical examination that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study in the opinion of the Investigator
- Clinically significant abnormalities in laboratory test results
- Confirmed resting pulse rate greater than 90 or less than 40 beats per minute (bpm) at screening
Show all 11Show fewer
- Confirmed systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening
- Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days of study start
- Any confirmed allergic reaction against any drug or multiple allergies
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- Infection with hepatitis B, hepatitis C virus, or HIV 1 and HIV 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Dose, Open-label, Two Parts, Two and Three Period Cross-over Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Fasting Following Oral Administration of RO4995819 in Healthy Subjects
This randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions.
- Conditions
- Healthy Volunteer
- Being tested
- RO4995819
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4995819Drug
Oral doses of RO4995819 (tablet)
RO4995819Drug
Oral doses of RO4995819 (capsule)
| Study group | Role | What they receive |
|---|---|---|
| RO4995819 capsule | Experimental | Not described Receives: Drug: RO4995819 |
| RO4995819 tablet | Experimental | Not described Receives: Drug: RO4995819 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability: Plasma concentration of RO4995819
Measured: Approximately 3 months
Secondary outcomes (1)
Safety: incidence of adverse events
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJun 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 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
- 52 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
- NCT01901159
- Sponsor's protocol ID
- BP28433
- Other IDs
- 2012-002710-39
- Status last verified
- Nov 2016
- First submitted
- 3 Jul 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 Randomized, Single Dose, Open-label, Two Parts, Two and Three Period Cross-over Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Fasting Following Oral Administration of RO4995819 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01901159
- Acronym / sponsor ID
- BP28433
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jul 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 randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO4995819 capsule | Experimental | Drug: RO4995819 |
| RO4995819 tablet | Experimental | Drug: RO4995819 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy non-smoking male and female volunteers, 18 to 65 years of age, inclusive.
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
- Willing not to participate in any other clinical trial with an investigational drug or device for at least 3 months following the follow up visit.
- Male volunteers and their partners of childbearing potential must use two adequate methods of contraception. Female volunteers who are not either surgically sterile or postmenopausal must commit to use two adequate methods of contraception throughout the study and until at least 5 months after last dosing.
Key exclusion criteria (11 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder or cancer
- Significant past or present disorders of the central nervous system, psychiatric disorders, behavioral disturbances
- Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
- Any condition or disease detected during the medical interview / physical examination that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study in the opinion of the Investigator
- Clinically significant abnormalities in laboratory test results
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 |
|---|---|---|
| RO4995819Oral doses of RO4995819 (tablet) | Drug | RO4995819 tablet |
| RO4995819Oral doses of RO4995819 (capsule) | Drug | RO4995819 capsule |
Primary outcome
Bioavailability: Plasma concentration of RO4995819
Time frame: Approximately 3 months
1 secondary outcome
Safety: incidence of adverse events
Time frame: Approximately 3 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
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 RO4995819 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 11 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?
Bioavailability: Plasma concentration of RO4995819 (time frame: Approximately 3 months). 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.