Healthy VolunteerPhase 1NCT01911611
A Study of RO6870868 in Healthy Volunteers
A Phase 1 study testing RO6870868 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be randomized to receive single ascending doses of either RO6870868 or placebo, with or without food. 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?
- RO6870868
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2013to Mar 2014
- 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
- Healthy male and female subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Women of non-childbearing potential including women who have undergone hysterectomy or bilateral oophorectomy and postmenopausal females
- Male subjects must be willing to use effective contraception as defined by protocol for the duration of the study and for one month after the last dose of study medication
- Body Mass Index (BMI) at screening of 18 to 32 kg/m2, inclusive
- Non-smokers, or use of < 10 cigarettes (or equivalent nicotine-containing product) per day
- No medical or social conditions that would potentially interfere with the subjects ability to comply with the study visit schedule or the study assessments
Who cannot join
- Pregnant (positive pregnancy test) or lactating women, and male partners of women who are pregnant or lactating
- History of drug or alcohol abuse within the last year
- History of immunologically mediated disease
- History or symptoms of any significant disease including (but not limited to) neurological, cardiovascular, endocrine, respiratory, gastrointestinal, hepatic, or renal disorder
- Personal or family history of congenital long QT syndrome or sudden death
- Evidence of an active or suspected cancer or a history of malignancy where in the investigator's opinion, there is a risk of recurrence. History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic oral or inhaled corticosteroids) </= 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
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- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- History of significant psychiatric disease
- Significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration
- History of gastrointestinal disease including inflammatory bowel disease, peptic ulcer disease, gastrointestinal hemorrhage
- Inadequate hematologic, renal or liver function
- Positive for hepatitis A, hepatitis B, hepatitis C, or HIV infection
- History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening, 48 hours before admission, 48 hours after each dose, and 48 hours before each scheduled visit
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Subjects who had received IFN or peginterferon within 8 weeks prior to dosing
- Participation in other clinical studies of a new chemical entity within 60 days prior to study randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of RO6870868
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be randomized to receive single ascending doses of either RO6870868 or placebo, with or without food.
- Conditions
- Healthy Volunteer
- Being tested
- RO6870868, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6870868Drug
Single ascending doses
placeboDrug
Single ascending doses
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| RO6870868 | Experimental | Not described Receives: Drug: RO6870868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: up to 44 days
Secondary outcomes (4)
Pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 48 hours post-dose
Pharmacokinetics: Maximum plasma concentration (Cmax)
Measured: Pre-dose and up to 48 hours post-dose
Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 48 hours post-dose
Pharmacodynamics: Cytokines/neopterin levels
Measured: Pre-dose and up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT01911611
- Sponsor's protocol ID
- NP28628
- Status last verified
- Jul 2018
- First submitted
- 26 Jul 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of RO6870868
- ClinicalTrials.gov ID
- NCT01911611
- Acronym / sponsor ID
- NP28628
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Jul 2013 (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, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be randomized to receive single ascending doses of either RO6870868 or placebo, with or without food.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo |
| RO6870868 | Experimental | Drug: RO6870868 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Women of non-childbearing potential including women who have undergone hysterectomy or bilateral oophorectomy and postmenopausal females
- Male subjects must be willing to use effective contraception as defined by protocol for the duration of the study and for one month after the last dose of study medication
- Body Mass Index (BMI) at screening of 18 to 32 kg/m2, inclusive
- Non-smokers, or use of < 10 cigarettes (or equivalent nicotine-containing product) per day
Key exclusion criteria (16 listed)
- Pregnant (positive pregnancy test) or lactating women, and male partners of women who are pregnant or lactating
- History of drug or alcohol abuse within the last year
- History of immunologically mediated disease
- History or symptoms of any significant disease including (but not limited to) neurological, cardiovascular, endocrine, respiratory, gastrointestinal, hepatic, or renal disorder
- Personal or family history of congenital long QT syndrome or sudden death
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 |
|---|---|---|
| RO6870868Single ascending doses | Drug | RO6870868 |
| placeboSingle ascending doses | Drug | Placebo |
Primary outcome
Safety: Incidence of adverse events
Time frame: up to 44 days
4 secondary outcomes
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: Pre-dose and up to 48 hours post-dose
Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
Pharmacodynamics: Cytokines/neopterin levels
Time frame: Pre-dose and up to 48 hours post-dose
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 26 Jul 2018.
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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
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 RO6870868 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 6 inclusion and 16 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 26 Jul 2018. 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?
Safety: Incidence of adverse events (time frame: up to 44 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 26 Jul 2018.