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This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| digoxin then digoxin + vandetanib | Experimental | Digoxin alone followed by digoxin in combination with vandetanib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Oral tablets 0.25mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for digoxin administered alone and in combination with vandetanib 300 mg | Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose | |
| Cmax for digoxin administered alone and in combination with vandetanib 300 mg | Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events | Treatment period + 7-14 days | |
| ECG data | Treatment period + 7-14 days | |
| Laboratory data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25117183 | Derived | Johansson S, Read J, Oliver S, Steinberg M, Li Y, Lisbon E, Mathews D, Leese PT, Martin P. Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine. Clin Pharmacokinet. 2014 Sep;53(9):837-47. doi: 10.1007/s40262-014-0161-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| C452423 | vandetanib |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Vandetanib |
| Drug |
Oral tablets, 300 mg, single dose |
|
| Treatment period + 7-14 days |
| Vital signs data | Treatment period + 7-14 days |
| Other PK parameters for digoxin administered alone and in combination with vandetanib 300 mg | Predose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 18, 30, 48, 72, 96, 120, 144, and 168 hrs post dose |
| Digoxin PK parameters for vandetanib in combination with digoxin | Predose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72, and 96 hrs post dose |
| CSR-D4200C00100.pdf | View source |
| Revised\_CSP\_redacted | View source |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |