Healthy VolunteerPhase 1NCT01654211
A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
A Phase 1 study testing danoprevir and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 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, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
Who cannot join
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers
This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- danoprevir, placebo, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danoprevirDrug
single iv infusion
danoprevirDrug
single oral dose
placeboDrug
single iv infusion
ritonavirDrug
oral doses
| Study group | Role | What they receive |
|---|---|---|
| Part 1: iv danoprevir | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 1: placebo | Placebo comparator | Not described Receives: Drug: placebo; Drug: ritonavir |
| Part 2 A: iv danoprevir | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 2 B: oral danoprevir | Active comparator | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 2 C: ritonavir | Active comparator | Not described Receives: Drug: ritonavir |
| Part 3 D: iv danoprevir | Experimental | Not described Receives: Drug: danoprevir; Drug: ritonavir |
| Part 3 E: iv danoprevir + cyclosporine | 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: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 12 hours post-dose
Safety: Incidence of adverse events
Measured: approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 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
- NCT01654211
- Sponsor's protocol ID
- NP28297
- Other IDs
- 2012-000470-40
- Status last verified
- Nov 2016
- First submitted
- 27 Jul 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 Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01654211
- Acronym / sponsor ID
- NP28297
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Jul 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 three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: iv danoprevir | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 1: placebo | Placebo comparator | Drug: placebo, Drug: ritonavir |
| Part 2 A: iv danoprevir | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 2 B: oral danoprevir | Active comparator | Drug: danoprevir, Drug: ritonavir |
| Part 2 C: ritonavir | Active comparator | Drug: ritonavir |
| Part 3 D: iv danoprevir | Experimental | Drug: danoprevir, Drug: ritonavir |
| Part 3 E: iv danoprevir + cyclosporine | Experimental | Drug: danoprevir, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
Key exclusion criteria (3 listed)
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
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 |
|---|---|---|
| danoprevirsingle iv infusion | Drug | Part 1: iv danoprevir, Part 2 A: iv danoprevir, Part 3 D: iv danoprevir, Part 3 E: iv danoprevir + cyclosporine |
| danoprevirsingle oral dose | Drug | Part 2 B: oral danoprevir |
| placebosingle iv infusion | Drug | Part 1: placebo |
| ritonaviroral doses | Drug | Part 1: iv danoprevir, Part 1: placebo, Part 2 A: iv danoprevir, Part 2 B: oral danoprevir, Part 2 C: ritonavir, Part 3 D: iv danoprevir, Part 3 E: iv danoprevir + cyclosporine |
Primary outcome
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 12 hours post-dose
Safety: Incidence of adverse events
Time frame: approximately 7 months
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.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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
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 and ritonavir in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
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 1 inclusion and 3 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 the concentration-time curve (AUC) (time frame: Pre-dose and up to 12 hours post-dose). The study lists 2 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.