Healthy VolunteerPhase 1NCT02281786
A Study of RO6926496 in Healthy Volunteers
A Phase 1 study testing RO6926496 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO6926496
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Oct 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
- A body mass index between 18 and 30 kg/m2
- Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study
Who cannot join
- Positive hepatitis B, hepatitis C, or HIV infection
- History of any clinically significant disease or disorder
- Clinically significant abnormalities in laboratory test results
- Participation in an investigational drug or device study within 90 days prior to screening
- Concomitant disease or condition that could interfere with, or treatment of which 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
- History or presence of clinically significant ECG abnormalities
Show all 9Show fewer
- Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period
- Any clinically relevant history of hypersensitivity or allergic reactions
- Any familial history of early onset Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS
This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RO6926496
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo to RO6926496
RO6926496Drug
single, ascending dose, intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
| Cohort 2 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
| Cohort 3 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
| Cohort 4 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
| Cohort 5 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
| Cohort 6 | Experimental | 8 volunteers (6 active, 2 placebo) Receives: Drug: Placebo; Drug: RO6926496 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 16 weeks
Secondary outcomes (1)
Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT02281786
- Sponsor's protocol ID
- BP29462
- Other IDs
- 2014-003170-16, 2014
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2014
- 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 SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT02281786
- Acronym / sponsor ID
- BP29462
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Nov 2014 (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 is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
| Cohort 2 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
| Cohort 3 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
| Cohort 4 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
| Cohort 5 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
| Cohort 6 | Experimental | Drug: Placebo, Drug: RO69264968 volunteers (6 active, 2 placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
- A body mass index between 18 and 30 kg/m2
- Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study
Key exclusion criteria (9 listed)
- Positive hepatitis B, hepatitis C, or HIV infection
- History of any clinically significant disease or disorder
- Clinically significant abnormalities in laboratory test results
- Participation in an investigational drug or device study within 90 days prior to screening
- Concomitant disease or condition that could interfere with, or treatment of which 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
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 |
|---|---|---|
| PlaceboMatching placebo to RO6926496 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| RO6926496single, ascending dose, intravenous administration | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 16 weeks
1 secondary outcome
Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance
Time frame: Up to 16 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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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 RO6926496 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
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 9 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 Kingdom. 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?
Incidence of adverse events (AEs) (time frame: Up to 16 weeks). 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.