Healthy VolunteerPhase 1NCT01392755
A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
A Phase 1 study testing danoprevir, omeprazole and ranitidine in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- danoprevir, omeprazole and ranitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy volunteers, aged 18 to 45 years, inclusive
- Weight >/= 50.0 kg
- Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive
Who cannot join
- Presence of any active or chronic disease
- Abnormal blood pressure
- Abnormal resting heart rate
- Abnormal ECG values
- History of any clinically significant cardiovascular or cerebrovascular disease
- Current smokers or subjects that have discontinued smoking < 6 months prior to first dose of study drug
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- Positive for hepatitis B, hepatitis C or HIV
- Positive test for drugs of abuse or alcohol
- Positive result for H. pylori
- Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
- History of clinically significant gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, omeprazole, ranitidine, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
oral doses of danoprevir
omeprazoleDrug
oral doses of omeprazole
ranitidineDrug
oral dose of ranitidine
ritonavirDrug
oral doses of ritonavir
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| 2 | Experimental | Not described Receives: Drug: danoprevir; Drug: omeprazole; Drug: ranitidine; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Measured: 1 day
Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Measured: 1 day
Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Measured: 1 day
Secondary outcomes (1)
Safety: Incidence of adverse events
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01392755
- Sponsor's protocol ID
- NP25291
- Status last verified
- Nov 2016
- First submitted
- 11 Jul 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 to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01392755
- Acronym / sponsor ID
- NP25291
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Jul 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 randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: danoprevir, Drug: ritonavir |
| 2 | Experimental | Drug: danoprevir, Drug: omeprazole, Drug: ranitidine, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult healthy volunteers, aged 18 to 45 years, inclusive
- Weight >/= 50.0 kg
- Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive
Key exclusion criteria (11 listed)
- Presence of any active or chronic disease
- Abnormal blood pressure
- Abnormal resting heart rate
- Abnormal ECG values
- History of any clinically significant cardiovascular or cerebrovascular disease
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 |
|---|---|---|
| danopreviroral doses of danoprevir | Drug | 1, 2 |
| omeprazoleoral doses of omeprazole | Drug | 2 |
| ranitidineoral dose of ranitidine | Drug | 2 |
| ritonaviroral doses of ritonavir | Drug | 1, 2 |
Primary outcome
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Time frame: 1 day
Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Time frame: 1 day
Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
Time frame: 1 day
1 secondary outcome
Safety: Incidence of adverse events
Time frame: Approximately 6 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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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 danoprevir, omeprazole and ranitidine in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
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 3 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 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?
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir (time frame: 1 day). The study lists 3 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.