Healthy VolunteerPhase 1NCT01802853
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
A Phase 1 study testing RO6811135 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at… 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?
- RO6811135
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Jun 2013
- 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
- Male healthy volunteers, 18-45 years of age inclusive
- Healthy as determined by screening assessments
- Body mass index (BMI) between 18-30 kg/m2
Who cannot join
- Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
- History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
- Any history of alcohol and/or drug of abuse addiction during the past 5 years
- Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
- Any clinically relevant abnormal test results prior to first dosing
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.
This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.
- Conditions
- Healthy Volunteer
- Being tested
- RO6811135
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6811135Drug
Single subcutaneous dose
RO6811135Drug
Single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| A: RO6811135 s.c. | Experimental | Not described Receives: Drug: RO6811135 |
| B: RO6811135 i.v. | Active comparator | Not described Receives: Drug: RO6811135 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
Measured: 48 hours
Secondary outcomes (3)
Safety: Incidence of adverse events
Measured: approximately 5 weeks
Pharmacodynamics: Fasting serum glucose/serum insulin
Measured: 48 hours
Nausea scale: Visual analogue scale
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT01802853
- Sponsor's protocol ID
- BP28438
- Other IDs
- 2012-005773-31
- Status last verified
- Nov 2016
- First submitted
- 28 Feb 2013
- 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
- Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01802853
- Acronym / sponsor ID
- BP28438
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Mar 2013 (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 open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: RO6811135 s.c. | Experimental | Drug: RO6811135 |
| B: RO6811135 i.v. | Active comparator | Drug: RO6811135 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male healthy volunteers, 18-45 years of age inclusive
- Healthy as determined by screening assessments
- Body mass index (BMI) between 18-30 kg/m2
Key exclusion criteria (7 listed)
- Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
- History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
- Any history of alcohol and/or drug of abuse addiction during the past 5 years
- Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
- Any clinically relevant abnormal test results prior to first dosing
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 |
|---|---|---|
| RO6811135Single subcutaneous dose | Drug | A: RO6811135 s.c. |
| RO6811135Single intravenous dose | Drug | B: RO6811135 i.v. |
Primary outcome
Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
Time frame: 48 hours
3 secondary outcomes
Safety: Incidence of adverse events
Time frame: approximately 5 weeks
Pharmacodynamics: Fasting serum glucose/serum insulin
Time frame: 48 hours
Nausea scale: Visual analogue scale
Time frame: 48 hours
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 RO6811135 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 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 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?
Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC) (time frame: 48 hours). 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.