Healthy VolunteerPhase 1NCT01592331
A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
A Phase 1 study testing RO5508887 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers. Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO5508887
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male 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
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug
- Donation of blood over 500 mL within 6 weeks before drug administration
Who cannot join
- Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Allergy to lidocaine
- Suspicion of regular consumption of drug of abuse
- Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
- Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure
- Donation of blood over 500 mL within 6 weeks before drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.
Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RO5508887
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single oral dose
RO5508887Drug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RO5508887 | Experimental | Not described Receives: Drug: RO5508887 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of amyloid biomarkers
Measured: Pre-dose and up to fullow up, 8-12 days post dose
Cerebral spinal fluid levels of amyloid biomarkers
Measured: Pre-dose and up to 30 hours post-dose
Secondary outcomes (2)
Safety: Incidence of adverse events
Measured: approximately 6 months
Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)
Measured: Pre-dose and up to 72 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 posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT01592331
- Sponsor's protocol ID
- WP27959
- Status last verified
- Nov 2016
- First submitted
- 19 Apr 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 Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01592331
- Acronym / sponsor ID
- WP27959
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 May 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 randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.
Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| RO5508887 | Experimental | Drug: RO5508887 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male 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
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug
- Donation of blood over 500 mL within 6 weeks before drug administration
Key exclusion criteria (7 listed)
- Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Allergy to lidocaine
- Suspicion of regular consumption of drug of abuse
- Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- Positive for hepatitis B, hepatitis C or HIV 1 or 2 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 |
|---|---|---|
| PlaceboSingle oral dose | Drug | Placebo |
| RO5508887Single oral dose | Drug | RO5508887 |
Primary outcome
Plasma levels of amyloid biomarkers
Time frame: Pre-dose and up to fullow up, 8-12 days post dose
Cerebral spinal fluid levels of amyloid biomarkers
Time frame: Pre-dose and up to 30 hours post-dose
2 secondary outcomes
Safety: Incidence of adverse events
Time frame: approximately 6 months
Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)
Time frame: Pre-dose and up to 72 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 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 RO5508887 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 4 inclusion and 7 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. 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?
Plasma levels of amyloid biomarkers (time frame: Pre-dose and up to fullow up, 8-12 days 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.