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A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Treatment A: A single oral dose of adagrasib 400 mg (2 × 200-mg tablets) on Day 1; |
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| Treatment B | Active Comparator | Treatment B: A single oral dose of eltrombopag 75 mg (1 × 75-mg tablet) plus adagrasib 400 mg (2 × 200-mg tablets) on Day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adagrasib | Drug | Adagrasib |
| |
| Eltrombopag + adagrasib |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - AUC (adagrasib) | Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC∞) | Days 1 and 8 |
| Pharmacokinetics - AUC (adagrasib) | AUC from time zero to the last quantifiable concentration (AUClast) | Days 1 and 8 |
| Pharmacokinetics - Cmax (adagrasib) | Maximum observed plasma concentration (Cmax) | Days 1 and 8 |
| Pharmacokinetics - Tmax (adagrasib) | Time to reach Cmax (tmax) | Days 1 and 8 |
| Pharmacokinetics - t1/2 (adagrasib) | Elimination half-life (t1/2) | Days 1 and 8 |
| Pharmacokinetics - CL/F (adagrasib) | Apparent total plasma clearance (CL/F) | Days 1 and 8 |
| Pharmacokinetics - Vz/F (adagrasib) | Apparent volume of distribution (Vz/F) | Days 1 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Incidence and severity of AEs | Up to 8 weeks from screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Daytona Beach (Labcorp Clinical Research Unit Daytona Beach) | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C000718190 | adagrasib |
| C520809 | eltrombopag |
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One-sequence Crossover Study
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| Drug |
Eltrombopag + adagrasib |
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