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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002269-36 | EudraCT Number |
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This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on study treatment is one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aleglitazar / digoxin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | Multiple doses of aleglitazar |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration time curve | Approximately 1 month | |
| Pharmacokinetics: maximum plasma concentration | Approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Elimination half-life | Approximately 1 month | |
| Pharmacokinetics: Time to maximum plasma concentration | Approximately 1 month | |
| Pharmacokinetics: Renal clearance |
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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 |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| digoxin |
| Drug |
Single dose of digoxin |
|
| Approximately 1 month |
| Pharmacokinetics: Apparent volume of distribution | Approximately 1 month |
| Pharmacokinetics: Apparent clearance | Approximately 1 month |
| Pharmacokinetics: Amount excreted in the urine | Approximately 1 month |
| Pharmacokinetics: Fraction of drug excreted in urine | Approximately 1 month |
| Safety: Incidence of adverse events | Approximately 2 months |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |