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This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized, double-blind, placebo-controlled study. Participants will be randomized to receive daily, oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control, parallel group study. Participants will be randomized to receive either multiple or single doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic parameters will be assessed for Parts A and B; and continuous ECG recordings will be made during Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Placebo | Placebo Comparator |
| |
| Part A: RO4602522 | Experimental |
| |
| Part B: RO4602522 Multiple Doses | Experimental |
| |
| Part B: RO4602522 Single Dose | Experimental |
| |
| Part B: moxifloxacin Single Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo RO4602522 | Other | Daily oral doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence of adverse events | Up to 30 days | |
| Part B: Continuous, 12-lead, Holter electrocardiogram (ECG) recordings | Days -1 (screening) to 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A & B: Area under the concentration-time curve (AUC) of RO4602522 | Days 1 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
Part B
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| RO4602522 | Drug | Daily oral doses |
|
| RO4602522 | Drug | Single, oral dose |
|
| moxifloxacin | Drug | 400 mg oral dose given on Day 1 or 11 |
|
| moxifloxacin placebo | Other | Dose given orally on Days 1 and/or 11 |
|
| ID | Term |
|---|---|
| C000614721 | sembragiline |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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