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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001127-57 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
| |
| Treatment C | Placebo Comparator |
| |
| Treatment D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin | Drug | Single oral dose on Day 1 |
| |
| Moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in QTcF interval at steady state | Baseline and Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of electrocardiogram | Baseline and Day 10 | |
| Correlation of RO4917838 plasma concentration and the electrocardiogram | Day 10 | |
| Change in the QTc interval, using moxifloxacin as an active control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | 85283 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22980315 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Single oral dose on Day 11 |
|
| RO4917838 | Drug | Multiple daily low doses of RO4917838 for 10 days |
|
| RO4917838 | Drug | Multiple daily oral high doses of RO4917838 for 10 days |
|
| RO4917838 placebo | Drug | Oral daily doses of placebo to RO4917838 for 10 days |
|
| Days 1 and 11 |
| Safety: incidence of adverse events | 8 weeks |
| Pharmacokinetics: area under the concentration time curve of RO4917838 | Up to Day 19 |
| Pharmacokinetics: Maximum plasma concentration of RO4917838 | Up to Day 19 |
| Strasbourg |
| 67064 |
| France |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |