Healthy VolunteerPhase 1NCT01613040
A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers
A Phase 1 study testing Moxifloxacin and RO4917838 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in 2 countries.
Trial summary
This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. 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?
- Moxifloxacin and RO4917838
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Jul 2009
- 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 volunteers aged 18 to 65 years inclusive
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
- Have no contraindications from the following: a detailed medical and surgical history, and a complete physical examination
- Able to participate, and willing to give written informed consent and to comply with the study restrictions
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, mental, cardiac, vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- History of alcohol and/or drug abuse or addiction within the last 2 years prior to Day 1 of the study.
- Consumption of nicotine and/or tobacco containing products within the last 3 months prior to Day 1 of the study.
- Infection with human immunodeficiency virus, hepatitis B and/or hepatitis C
- 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 Investigator.
- Positive drug screen or alcohol test at screening or prior to enrollment.
- Coffee or tea consumption > 10 cups per day or methylxanthine containing drinks >1.5 liter/day or more than 250 g/day of chocolate.
- Alcohol consumption averaging > 3 drinks daily
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multiple-center, Multiple-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Parallel Group Study to Investigate the Effect of RO4917838 on the QTc Interval in Healthy Subjects.
This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.
- Conditions
- Healthy Volunteer
- Being tested
- Moxifloxacin, RO4917838, RO4917838 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Single oral dose on Day 1
MoxifloxacinDrug
Single oral dose on Day 11
RO4917838Drug
Multiple daily low doses of RO4917838 for 10 days
RO4917838Drug
Multiple daily oral high doses of RO4917838 for 10 days
RO4917838 placeboDrug
Oral daily doses of placebo to RO4917838 for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: RO4917838 |
| Treatment B | Experimental | Not described Receives: Drug: RO4917838 |
| Treatment C | Placebo comparator | Not described Receives: Drug: Moxifloxacin; Drug: RO4917838 placebo |
| Treatment D | Placebo comparator | Not described Receives: Drug: Moxifloxacin; Drug: RO4917838 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in QTcF interval at steady state
Measured: Baseline and Day 10
Secondary outcomes (6)
Change of electrocardiogram
Measured: Baseline and Day 10
Correlation of RO4917838 plasma concentration and the electrocardiogram
Measured: Day 10
Change in the QTc interval, using moxifloxacin as an active control
Measured: Days 1 and 11
Safety: incidence of adverse events
Measured: 8 weeks
Pharmacokinetics: area under the concentration time curve of RO4917838
Measured: Up to Day 19
Pharmacokinetics: Maximum plasma concentration of RO4917838
Measured: Up to Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 169 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
- NCT01613040
- Sponsor's protocol ID
- BP21705
- Other IDs
- 2008-001127-57, 2008
- Status last verified
- Nov 2016
- First submitted
- 23 May 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Hofmann C, Banken L, Hahn M, Swearingen D, Nagel S, Martin-Facklam M. Evaluation of the effects of bitopertin (RG1678) on cardiac repolarization: a thorough corrected QT study in healthy male volunteers. Clin Ther. 2012 Oct;34(10):2061-71. doi: 10.1016/j.clinthera.2012.08.010. Epub 2012 Sep 12.
PubMed 22980315
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 Multiple-center, Multiple-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Parallel Group Study to Investigate the Effect of RO4917838 on the QTc Interval in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01613040
- Acronym / sponsor ID
- BP21705
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Jun 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 multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: RO4917838 |
| Treatment B | Experimental | Drug: RO4917838 |
| Treatment C | Placebo comparator | Drug: Moxifloxacin, Drug: RO4917838 placebo |
| Treatment D | Placebo comparator | Drug: Moxifloxacin, Drug: RO4917838 placebo |
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 volunteers aged 18 to 65 years inclusive
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
- Have no contraindications from the following: a detailed medical and surgical history, and a complete physical examination
- Able to participate, and willing to give written informed consent and to comply with the study restrictions
Key exclusion criteria (8 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, mental, cardiac, vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- History of alcohol and/or drug abuse or addiction within the last 2 years prior to Day 1 of the study.
- Consumption of nicotine and/or tobacco containing products within the last 3 months prior to Day 1 of the study.
- Infection with human immunodeficiency virus, hepatitis B and/or hepatitis C
- 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 Investigator.
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 |
|---|---|---|
| MoxifloxacinSingle oral dose on Day 1 | Drug | Treatment C |
| MoxifloxacinSingle oral dose on Day 11 | Drug | Treatment D |
| RO4917838Multiple daily low doses of RO4917838 for 10 days | Drug | Treatment A |
| RO4917838Multiple daily oral high doses of RO4917838 for 10 days | Drug | Treatment B |
| RO4917838 placeboOral daily doses of placebo to RO4917838 for 10 days | Drug | Treatment C, Treatment D |
Primary outcome
Changes in QTcF interval at steady state
Time frame: Baseline and Day 10
6 secondary outcomes
Change of electrocardiogram
Time frame: Baseline and Day 10
Correlation of RO4917838 plasma concentration and the electrocardiogram
Time frame: Day 10
Change in the QTc interval, using moxifloxacin as an active control
Time frame: Days 1 and 11
Safety: incidence of adverse events
Time frame: 8 weeks
Pharmacokinetics: area under the concentration time curve of RO4917838
Time frame: Up to Day 19
Pharmacokinetics: Maximum plasma concentration of RO4917838
Time frame: Up to Day 19
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.
- Derived from this study: PubMed 22980315Hofmann C, Banken L, Hahn M, Swearingen D, Nagel S, Martin-Facklam M. Evaluation of the effects of bitopertin (RG1678) on cardiac repolarization: a thorough corrected QT study in healthy male volunteers. Clin Ther. 2012 Oct;34(10):2061-71. doi: 10.1016/j.clinthera.2012.08.010. Epub 2012 Sep 12.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin and RO4917838 in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in 2 countries.
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 8 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 2 sites in United States, France. 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?
Changes in QTcF interval at steady state (time frame: Baseline and Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613040, which also lists 1 linked publication.
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.