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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000261-31 | EudraCT Number |
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The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy RG1662 + itraconazole | Experimental | Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food |
|
| RG1662 Monotherapy | Experimental | Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.) |
|
| itraconazole Monotherapy | Experimental | Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1662 | Drug |
| ||
| itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from 0-t (AUC0-t) | Within 29 days | |
| Maximum observed plasma concentration (Cmax) | Within 29 days | |
| Time to maximum observed plasma concentration (Tmax) | Within 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF | Up to 29 days | |
| Incidence of adverse events | Within 43 days | |
| Clinically significant changes from baseline in physical examination or laboratory parameters |
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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 |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Within 29 days |
| Mean model parameters of RG1662 concentration vs. QTcF changes | Within 29 days |
| D010879 |
| Piperazines |