Healthy VolunteerPhase 1NCT01592890
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
A Phase 1 study testing RO4917523 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. 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?
- RO4917523
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to May 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
- Male adults, 18 to 65 years of age inclusive
- Body mass index (BMI) 18.0 to 32.0 kg/m2
- Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
- Medical history without major pathology
- Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug
Who cannot join
- History of relevant drug and or food allergies
- Smoking (within 60 days prior to drug administration until the follow-up visit)
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
- Infrequent bowel movements (less than once per 2 days)
- Participation in another ADME study with a radiation burden >0,1 mSv in the period of 1 years before the start of the study
Show all 9Show fewer
- Positive screen for drugs of abuse
- Average intake of more than 24 units of alcohol per week
- Positive for hepatitis B, hepatitis C or HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers
This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917523
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917523Drug
[14C]-labeled RO4917523, single oral dose
RO4917523Drug
[13C]-labeled RO4917523, single intravenous tracer dose
| Study group | Role | What they receive |
|---|---|---|
| [14C]-labeled RO4917523 | Experimental | Not described Receives: Drug: RO4917523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination: urinary and fecal recovery of total radioactivity
Measured: Pre-dose and up to approximately Day 18 post-dose
Plasma concentrations of RO4917523
Measured: Pre-dose and up to approximately Day 18 post-dose
Secondary outcomes (2)
Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling
Measured: Pre-dose and up to approximately Day 18 post-dose
Absolute bioavailability: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to approximately Day 18 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 startApr 2012
- Primary completionMay 2012
- Study completionMay 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT01592890
- Sponsor's protocol ID
- BP27854
- Other IDs
- 2011-004597-28
- Status last verified
- Nov 2016
- First submitted
- 4 May 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
- Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01592890
- Acronym / sponsor ID
- BP27854
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 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 single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-labeled RO4917523 | Experimental | Drug: RO4917523 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male adults, 18 to 65 years of age inclusive
- Body mass index (BMI) 18.0 to 32.0 kg/m2
- Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
- Medical history without major pathology
- Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug
Key exclusion criteria (9 listed)
- History of relevant drug and or food allergies
- Smoking (within 60 days prior to drug administration until the follow-up visit)
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
- Infrequent bowel movements (less than once per 2 days)
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 |
|---|---|---|
| RO4917523[14C]-labeled RO4917523, single oral dose | Drug | [14C]-labeled RO4917523 |
| RO4917523[13C]-labeled RO4917523, single intravenous tracer dose | Drug | [14C]-labeled RO4917523 |
Primary outcome
Elimination: urinary and fecal recovery of total radioactivity
Time frame: Pre-dose and up to approximately Day 18 post-dose
Plasma concentrations of RO4917523
Time frame: Pre-dose and up to approximately Day 18 post-dose
2 secondary outcomes
Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling
Time frame: Pre-dose and up to approximately Day 18 post-dose
Absolute bioavailability: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to approximately Day 18 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 RO4917523 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 5 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 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. 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?
Elimination: urinary and fecal recovery of total radioactivity (time frame: Pre-dose and up to approximately Day 18 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.