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This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is <50.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Normal Renal Function |
|
| 2 | Experimental | Mild Renal Impairment |
|
| 3 | Experimental | Moderate Renal Impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5024048 | Drug | multiple oral doses for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl | sampling days 1 and 3-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters | Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17 |
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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 |
|---|---|---|---|---|---|---|
| Orlando | Florida | 32809 | United States | |||
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| Knoxville |
| Tennessee |
| 37920 |
| United States |
| Christchurch | 8011 | New Zealand |