Healthy VolunteerPhase 1NCT01510899
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
A Phase 1 study testing RO4917838 in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in 2 countries.
Trial summary
This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4917838
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2011to Mar 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General criteria
- Body mass index (BMI) between 18 and 32 kg/m2
- Criteria applying to renal impaired subjects
- Adult subjects, 18-65 years of age
- Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
- Part 2: Subjects with severe, moderate or mild renal impairment
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- Stable renal function
- Criteria applying to healthy subjects
- Adult subjects, 18-70 years of age
Who cannot join
- General criteria
- Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
- Any condition which could relapse during or immediately after the study
- History of alcohol or drug abuse
- Criteria applying to renal impaired subjects
- Evidence of unstable clinically significant disease other than renal impairment
Show all 10Show fewer
- Clinically significant liver disease
- Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start
- Criteria applying to healthy subjects
- History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917838
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917838Drug
Single dose of RO4917838
RO4917838Drug
Single dose of RO4917838
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects Arm | Experimental | Not described Receives: Drug: RO4917838 |
| Renal Impaired Subjects Arm | Experimental | Not described Receives: Drug: RO4917838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under concentration time curve of RO4917838
Measured: Days 1-16
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT01510899
- Sponsor's protocol ID
- BP25261
- Status last verified
- Nov 2016
- First submitted
- 12 Jan 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 Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
- ClinicalTrials.gov ID
- NCT01510899
- Acronym / sponsor ID
- BP25261
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Jan 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 open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects Arm | Experimental | Drug: RO4917838 |
| Renal Impaired Subjects Arm | Experimental | Drug: RO4917838 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- General criteria
- Body mass index (BMI) between 18 and 32 kg/m2
- Criteria applying to renal impaired subjects
- Adult subjects, 18-65 years of age
- Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
Key exclusion criteria (10 listed)
- General criteria
- Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
- Any condition which could relapse during or immediately after the study
- History of alcohol or drug abuse
- Criteria applying to renal impaired subjects
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 | Renal Impaired Subjects Arm |
| RO4917838Single dose of RO4917838 | Drug | Healthy Subjects Arm |
Primary outcome
Pharmacokinetics: Area under concentration time curve of RO4917838
Time frame: Days 1-16
1 secondary outcome
Safety: Incidence of adverse events
Time frame: 9 weeks
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO4917838 in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in 2 countries.
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 9 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 3 sites in Russia, 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?
Pharmacokinetics: Area under concentration time curve of RO4917838 (time frame: Days 1-16). 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.