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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002274-31 | EudraCT Number |
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This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | Single dose of aleglitazar in Periods 1, 2, 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the plasma concentration time curve | Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of adverse events | 14 weeks |
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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 |
|---|---|---|---|---|---|---|
| Manchester | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| rifampicin |
| Drug |
Single dose in Periods 1 and 2; multiple doses in Period 3 |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |