Healthy VolunteerPhase 1NCT01356550
A Study on The Effect of Hepatic 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 assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2011to Oct 2011
- 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:
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
- Healthy Subjects:
- Adult male or female subjects, 18-70 years of age
- Hepatically impaired patients:
- Adult patients, 18-65 years of age
- Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)
- Hepatic impairment should be primary and must not be a complication of an underlying primary disease
Who cannot join
- General:
- Pregnant or lactating women
- Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1
- Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
- Positive for HIV infection
- Renal insufficiency
Show all 17Show fewer
- Healthy volunteers:
- History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study
- Any history of depressive episodes or treatment with antidepressants
- Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1
- Positive for hepatitis B and/or hepatitis C infection
- Hepatically impaired patients:
- Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study
- Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment
- Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity
- Presence of surgically created or transjugular intrahepatic portal systemic shunts
- Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral 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 oral dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Drug: RO4917838 |
| Hepatic impairment | Experimental | Not described Receives: Drug: RO4917838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
Measured: 22 days
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
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
- 35 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
- NCT01356550
- Sponsor's protocol ID
- BP25260
- Other IDs
- 2010-023641-30
- Status last verified
- Nov 2016
- First submitted
- 18 May 2011
- 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 Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
- ClinicalTrials.gov ID
- NCT01356550
- Acronym / sponsor ID
- BP25260
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 May 2011 (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 assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral 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 | Experimental | Drug: RO4917838 |
| Hepatic impairment | Experimental | Drug: RO4917838 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
- Adult male or female subjects, 18-70 years of age
- Adult patients, 18-65 years of age
- Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)
- Hepatic impairment should be primary and must not be a complication of an underlying primary disease
Key exclusion criteria (17 listed)
- Pregnant or lactating women
- Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1
- Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
- Positive for HIV infection
- Renal insufficiency
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 oral dose | Drug | Healthy subjects, Hepatic impairment |
Primary outcome
Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
Time frame: 22 days
1 secondary outcome
Safety: Incidence of adverse events
Time frame: 29 days
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 8 inclusion and 17 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 of RO4917838 (area under the concentration-time curve, Cmax) (time frame: 22 days). 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.