Healthy VolunteerPhase 1NCT01209221
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
A Phase 1 study testing RO5271983 - MAD and RO5271983 - SAD in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial summary
This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. 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?
- RO5271983 - MAD and RO5271983 - SAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNew Zealand
- Study dates
- Sep 2010to Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, 18-65 years of age
- Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
- In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception
Who cannot join
- A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
- Clinical significant abnormalities in laboratory test results
- Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
- Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.
This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo - MAD, Placebo - SAD, RO5271983 - MAD, RO5271983 - SAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo - MADDrug
Once or twice daily doses of matching placebo to RO5271983 for 14 days
Placebo - SADDrug
Single dose of matching placebo to RO5271983 for up to 3 periods
RO5271983 - MADDrug
Once or twice daily doses of RO5271983 for 14 days
RO5271983 - SADDrug
Single dose of RO5271983 at each period (for up to 3 periods)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO5271983 - SAD |
| 2 | Experimental | Not described Receives: Drug: RO5271983 - MAD |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo - SAD |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo - MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
Measured: up to 240 hours
Single ascending dose (SAD): Safety (incidence of adverse events)
Measured: 14 weeks
Single ascending dose (SAD): Tolerability (e.g. vital signs)
Measured: 14 weeks
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
Measured: 17 days
Multiple ascending doses (MAD): Safety (incidence of adverse events)
Measured: 8 weeks
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
Measured: 8 weeks
Secondary outcomes (3)
Effect of food on pharmacokinetics of RO5271983
Measured: up to 240 hours
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
Measured: 72 hours
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 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
- NCT01209221
- Sponsor's protocol ID
- NP25342
- Status last verified
- Nov 2016
- First submitted
- 24 Sep 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
- A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01209221
- Acronym / sponsor ID
- NP25342
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Sep 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 placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO5271983 - SAD |
| 2 | Experimental | Drug: RO5271983 - MAD |
| 3 | Placebo comparator | Drug: Placebo - SAD |
| 4 | Placebo comparator | Drug: Placebo - MAD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers, 18-65 years of age
- Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
- In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception
Key exclusion criteria (4 listed)
- A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
- Clinical significant abnormalities in laboratory test results
- Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
- Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
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 |
|---|---|---|
| Placebo - MADOnce or twice daily doses of matching placebo to RO5271983 for 14 days | Drug | 4 |
| Placebo - SADSingle dose of matching placebo to RO5271983 for up to 3 periods | Drug | 3 |
| RO5271983 - MADOnce or twice daily doses of RO5271983 for 14 days | Drug | 2 |
| RO5271983 - SADSingle dose of RO5271983 at each period (for up to 3 periods) | Drug | 1 |
Primary outcome
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
Time frame: up to 240 hours
Single ascending dose (SAD): Safety (incidence of adverse events)
Time frame: 14 weeks
Single ascending dose (SAD): Tolerability (e.g. vital signs)
Time frame: 14 weeks
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
Time frame: 17 days
Multiple ascending doses (MAD): Safety (incidence of adverse events)
Time frame: 8 weeks
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
Time frame: 8 weeks
3 secondary outcomes
Effect of food on pharmacokinetics of RO5271983
Time frame: up to 240 hours
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
Time frame: 72 hours
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
Time frame: 14 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
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 RO5271983 - MAD and RO5271983 - SAD in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
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 4 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 New Zealand. 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?
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983 (time frame: up to 240 hours). The study lists 6 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; AzTrials last refreshed its copy on 26 Oct 2026.