Healthy VolunteerPhase 1NCT02179866
A Single-center Study to Investigate How Quickly and to What Extent a Radioactive Dose of RO5285119 is Absorbed, Metabolized and Eliminated From the Body of Healthy Male Volunteers
A Phase 1 study testing RO5285119 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants. Read more about this study
- Who is it for?
- Ages 35 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO5285119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Jul 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 35 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants, 35 to 64 years of age, inclusive
- For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug
- Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
- 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 a subject
- History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease
- History of myopathy or muscle disorder
Show all 11Show fewer
- History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
- Any CYP3A inhibitor within 2 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
- Any CYP3A inducer within 4 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
- Infrequent bowel movements (less than once per 24 hours on average)
- Regular work with ionizing radiation or radioactive material
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SINGLE-CENTER, OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO5285119 IN HEALTHY MALE SUBJECTS
This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.
- Conditions
- Healthy Volunteer
- Being tested
- RO5285119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5285119Drug
Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1
| Study group | Role | What they receive |
|---|---|---|
| [14C]-labeled RO5285119 | Experimental | Single oral dose - drinking solution Receives: Drug: RO5285119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered
Measured: Up to Day 17
Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax
Measured: Up to Day 17
Secondary outcomes (2)
Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces
Measured: Up to Day 17
Incidence of adverse events
Measured: Up to 28 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 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
- 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
- NCT02179866
- Sponsor's protocol ID
- BP29279
- Other IDs
- 2014-000277-40, 2014
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 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
- SINGLE-CENTER, OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO5285119 IN HEALTHY MALE SUBJECTS
- ClinicalTrials.gov ID
- NCT02179866
- Acronym / sponsor ID
- BP29279
- 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
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Jul 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 study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-labeled RO5285119 | Experimental | Drug: RO5285119Single oral dose - drinking solution |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male participants, 35 to 64 years of age, inclusive
- For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug
- Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug
Key exclusion criteria (11 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
- 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 a subject
- History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease
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 |
|---|---|---|
| RO5285119Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1 | Drug | [14C]-labeled RO5285119 |
Primary outcome
Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered
Time frame: Up to Day 17
Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax
Time frame: Up to Day 17
2 secondary outcomes
Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces
Time frame: Up to Day 17
Incidence of adverse events
Time frame: Up to 28 days after the last dose of study drug
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 RO5285119 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 3 inclusion and 11 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?
Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered (time frame: Up to Day 17). 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.