Healthy VolunteerPhase 1NCT01636492
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
A Phase 1 study testing bitopertin in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial summary
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- bitopertin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2005to Aug 2006
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteer, 18 to 60 years of age inclusive
- Body mass index (BMI) 19-35 kg/m2 inclusive
- Supine blood pressure within the normal range of the center and heart rate >/= 40 provided QTcB is <450 ms
- Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion
Who cannot join
- History or evidence of any clinically significant disease or disorder
- Clinically significant ECG abnormalities
- Positive for hepatitis B, hepatitis C or HIV infection
- Previous treatment with iron for iron deficiency anemia
- Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)
- History of alcohol and/or drug abuse or addiction within the last 2 years before study start
Show all 9Show fewer
- Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
- Participation in a clinical study with an investigational drug within the last three months prior to screening
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.
- Conditions
- Healthy Volunteer
- Being tested
- bitopertin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bitopertinDrug
Single oral dose
placeboDrug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Bitopertin | Experimental | Not described Receives: Drug: bitopertin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: 17 days
Secondary outcomes (2)
Pharmacokinetics: Area under the concentration-time curve
Measured: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose
Pharmacokinetics: Urine concentrations drug/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 posted10 Jul 2012 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
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
- 71 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
- NCT01636492
- Sponsor's protocol ID
- BP19292
- Status last verified
- Nov 2016
- First submitted
- 6 Jul 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 Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01636492
- Acronym / sponsor ID
- BP19292
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 10 Jul 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, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bitopertin | Experimental | Drug: bitopertin |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male healthy volunteer, 18 to 60 years of age inclusive
- Body mass index (BMI) 19-35 kg/m2 inclusive
- Supine blood pressure within the normal range of the center and heart rate >/= 40 provided QTcB is <450 ms
- Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion
Key exclusion criteria (9 listed)
- History or evidence of any clinically significant disease or disorder
- Clinically significant ECG abnormalities
- Positive for hepatitis B, hepatitis C or HIV infection
- Previous treatment with iron for iron deficiency anemia
- Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)
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 |
|---|---|---|
| bitopertinSingle oral dose | Drug | Bitopertin |
| placeboSingle oral dose | Drug | Placebo |
Primary outcome
Safety: Incidence of adverse events
Time frame: 17 days
2 secondary outcomes
Pharmacokinetics: Area under the concentration-time curve
Time frame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose
Pharmacokinetics: Urine concentrations drug/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 bitopertin in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
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 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 New Zealand. 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?
Safety: Incidence of adverse events (time frame: 17 days). 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.