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A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Oral adagrasib 200 mg twice daily (BID) for 8 days (Days 1 to 8). Predose PK blood samples for the measurement of adagrasib concentration will be collected on Days 2 to 7. Serial PK blood samples for adagrasib will be collected up to 12 hours postdose on Days 1 and 8. | ||
| Treatment B | Drug | Oral adagrasib 200 mg BID and gemfibrozil 600 mg BID for 10 days (Days 9 to 18), with no evening dose of adagrasib or gemfibrozil on Day 18. Predose PK blood samples for the measurement of adagrasib concentration will be collected on Days 9 to 17 before the morning dose of adagrasib. Predose PK blood samples for the measurement of gemfibrozil trough concentration will be collected on Days 15 to 18 before the morning dose of gemfibrozil. Serial PK blood samples for adagrasib will be collected up to 12 hours postdose on Day 18. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - AUC (adagrasib) | Area under the plasma concentration time curve (AUC) during a dosage interval (AUCtau) | Days 1, 8, and 18 |
| Pharmacokinetics - Cmax (adagrasib) | Maximum observed plasma concentration | Days 1, 8, and 18 |
| Pharmacokinetics - Tmax (adagrasib) | Time to reach Cmax (tmax) | Days 1, 8, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Incidence and severity of AEs | Up to 9 weeks from screening |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc | Dallas | Texas | 75247 | United States |
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A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects
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