Healthy VolunteerPhase 1NCT01714154
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
A Phase 1 study testing danoprevir, ritonavir and setrobuvir in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in 2 countries.
Trial summary
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. 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?
- danoprevir, ritonavir and setrobuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2012to May 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
- Male and female adults, 18-65 years of age, inclusive
- Weight >/= 45.0 kg
- Body mass index (BMI) 18.0 - 35.0 kg/m2, inclusive
- Females of childbearing potential and males and their female partners of childbearing potential must agree to use two forms of non-hormonal contraception as defined by protocol
- Subjects with a history of substance abuse may be enrolled provided they have not abused drugs or alcohol for at least 6 months
- Healthy subjects only:
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- Medical history without major recent or ongoing pathology Laboratory values at screening and Day -1 within the normal range or showing no clinically relevant deviations
- Subjects with hepatic impairment only:
- Stable mild liver disease (Child-Pugh A) of cryptogenic, post-hepatic, hepatitis B/C, or alcoholic origin Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days Must be on stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication
Who cannot join
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Active infection or febrile illness </= 10 days prior to the first dose of study medication
- Uncontrolled/untreated hypertension
- Inadequate renal function
- Positive urine drug screen or positive breath alcohol test at screening and on Day -1 of each period
- An average alcohol intake of more than 2 units per day or 14 units per week until 48 hours prior to enrollment
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- History of any significant drug-related allergy or hepatotoxicity
- Participation in other clinical studies with an investigational drug or new chemical entity within 3 months (6 months for biologic therapies) prior to the first dose of study medication
- Positive for HIV infection
- Any clinically significant cardiovascular or cerebrovascular disease
- Healthy subjects only:
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, absorption of medication, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Positive screening test for HBsAg or HCV antibody
- Subjects with hepatic impairment only:
- Severe ascites at screening or Day -1 History of or current severe hepatic encephalopathy (Grade 3 or higher) Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver Positive screening test for HCV antigen
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Multi Center, Sequential, Open-Label, Multiple-Dose Study of Setrobuvir (STV) Alone and With Co-Administration of Ritonavir-boosted Danoprevir to Evaluate the Safety, Tolerability and Pharmacokinetics of STV, DNV, and Ritonavir (RTV) in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, ritonavir, setrobuvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
100 mg orally every 12 hours
ritonavirDrug
100 mg orally every 12 hours
setrobuvirDrug
200 mg orally every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| A: setrobuvir | Experimental | Not described Receives: Drug: setrobuvir |
| B: setrobuvir + DNV/r | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir; Drug: setrobuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: approximately 40 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Measured: up to 16 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h)
Measured: up to 16 days
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
Measured: up to 16 days
Secondary outcomes (7)
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Measured: up to 16 days
Pharmacokinetics: Elimination half-life (t1/2)
Measured: up to 16 days
Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)
Measured: up to 16 days
Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)
Measured: up to 16 days
Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)
Measured: up to 16 days
Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Measured: up to 12 days
Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Measured: up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01714154
- Sponsor's protocol ID
- NP28326
- Other IDs
- 2012-002283-28
- Status last verified
- Nov 2016
- First submitted
- 23 Oct 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 Multi Center, Sequential, Open-Label, Multiple-Dose Study of Setrobuvir (STV) Alone and With Co-Administration of Ritonavir-boosted Danoprevir to Evaluate the Safety, Tolerability and Pharmacokinetics of STV, DNV, and Ritonavir (RTV) in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT01714154
- Acronym / sponsor ID
- NP28326
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Oct 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 multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: setrobuvir | Experimental | Drug: setrobuvir |
| B: setrobuvir + DNV/r | Experimental | Drug: danoprevir, Drug: ritonavir, Drug: setrobuvir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female adults, 18-65 years of age, inclusive
- Weight >/= 45.0 kg
- Body mass index (BMI) 18.0 - 35.0 kg/m2, inclusive
- Females of childbearing potential and males and their female partners of childbearing potential must agree to use two forms of non-hormonal contraception as defined by protocol
- Subjects with a history of substance abuse may be enrolled provided they have not abused drugs or alcohol for at least 6 months
Key exclusion criteria (14 listed)
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Active infection or febrile illness </= 10 days prior to the first dose of study medication
- Uncontrolled/untreated hypertension
- Inadequate renal function
- Positive urine drug screen or positive breath alcohol test at screening and on Day -1 of each period
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 |
|---|---|---|
| danoprevir100 mg orally every 12 hours | Drug | B: setrobuvir + DNV/r |
| ritonavir100 mg orally every 12 hours | Drug | B: setrobuvir + DNV/r |
| setrobuvir200 mg orally every 12 hours | Drug | A: setrobuvir, B: setrobuvir + DNV/r |
Primary outcome
Safety: Incidence of adverse events
Time frame: approximately 40 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
Time frame: up to 16 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h)
Time frame: up to 16 days
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
Time frame: up to 16 days
7 secondary outcomes
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Time frame: up to 16 days
Pharmacokinetics: Elimination half-life (t1/2)
Time frame: up to 16 days
Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)
Time frame: up to 16 days
Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)
Time frame: up to 16 days
Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)
Time frame: up to 16 days
Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Time frame: up to 12 days
Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)
Time frame: up to 12 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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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 danoprevir, ritonavir and setrobuvir 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 14 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 Hungary, Poland. 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?
Safety: Incidence of adverse events (time frame: approximately 40 days). The study lists 4 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.