A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers
NCT ID: NCT01613040
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
169 participants
INTERVENTIONAL
2009-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Treatment A
RO4917838
Multiple daily low doses of RO4917838 for 10 days
Treatment B
RO4917838
Multiple daily oral high doses of RO4917838 for 10 days
Treatment C
Moxifloxacin
Single oral dose on Day 1
RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days
Treatment D
Moxifloxacin
Single oral dose on Day 11
RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days
Interventions
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Moxifloxacin
Single oral dose on Day 1
Moxifloxacin
Single oral dose on Day 11
RO4917838
Multiple daily low doses of RO4917838 for 10 days
RO4917838
Multiple daily oral high doses of RO4917838 for 10 days
RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tempe, Arizona, United States
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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2008-001127-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP21705
Identifier Type: -
Identifier Source: org_study_id