Healthy VolunteerPhase 1NCT01185873
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
A Phase 1 study testing danoprevir and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 5 sites in 3 countries.
Trial summary
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. 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?
- danoprevir and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2011to Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers:
- Adult healthy volunteers, 18-70 years of age
- Weight >/=50.0 kg
- Body Mass Index (BMI) 18.0-40.0 kg/m2
- Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
- Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
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- Medical history without major recent or ongoing pathology
- Patients with hepatic impairment:
- Adult patients, 18-70 years of age
- Weight >/=50.0 kg
- Body Mass Index (BMI) 18.0-40.0 kg/m2
- Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
- Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
- Stable, mild, moderate, or severe liver disease of cryptogenic, post-hepatic, hepatitis B or alcoholic origin
Who cannot join
- Healthy Volunteers:
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
- Any history of clinically significant cardiovascular or cerebrovascular disease
- Creatinine clearance </=60 mL/min
- Positive test results for drugs or alcohol
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- Donation or loss of blood over 450 ml within 60 days prior to screening
- Patients with hepatic impairment:
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
- Any history of clinically significant cardiovascular or cerebrovascular disease
- Severe ascites at screening or admission to the clinic
- History of or current severe hepatic encephalopathy (grade 3 or higher)
- Any evidence of progressive liver disease within the last 4 weeks
- History of liver transplantation
- Creatinine clearance </=60 mL/min
- Positive test results for drugs or alcohol
- Donation or loss of blood over 450 ml within 60 days prior to screening
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: The Effect of Hepatic Impairment on the Pharmacokinetics of RO5190591/Ritonavir: A Multiple-Center, Open-Label Study Following Multiple Oral Doses of RO5190591/Ritonavir to Subjects With Mild, Moderate, or Severe Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
Repeated oral doses
ritonavirDrug
Repeated oral doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment
Measured: From baseline to day 10
Secondary outcomes (1)
Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment
Measured: From baseline to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT01185873
- Sponsor's protocol ID
- NP25290
- Other IDs
- 2010-020314-29
- Status last verified
- Nov 2016
- First submitted
- 17 Aug 2010
- 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
- The Effect of Hepatic Impairment on the Pharmacokinetics of RO5190591/Ritonavir: A Multiple-Center, Open-Label Study Following Multiple Oral Doses of RO5190591/Ritonavir to Subjects With Mild, Moderate, or Severe Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT01185873
- Acronym / sponsor ID
- NP25290
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2010 (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 non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: danoprevir, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult healthy volunteers, 18-70 years of age
- Weight >/=50.0 kg
- Body Mass Index (BMI) 18.0-40.0 kg/m2
- Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
- Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
Key exclusion criteria (18 listed)
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
- Any history of clinically significant cardiovascular or cerebrovascular disease
- Creatinine clearance </=60 mL/min
- Positive test results for drugs or alcohol
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 |
|---|---|---|
| danoprevirRepeated oral doses | Drug | 1 |
| ritonavirRepeated oral doses | Drug | 1 |
Primary outcome
Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment
Time frame: From baseline to day 10
1 secondary outcome
Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment
Time frame: From baseline to day 10
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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing danoprevir and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 5 sites in 3 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 14 inclusion and 18 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 5 sites in Czechia, Slovakia, United States. 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 (plasma concentration) of danoprevir in patients with hepatic impairment (time frame: From baseline to day 10). 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.