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This is a Phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive a single oral dose of Divarasib on Day 1. |
|
| Treatment B | Experimental | Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divarasib | Drug | Divarasib will be administered as a single oral dose as specified for the respective period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Divarasib | Day 1 of Period 1 and Day 5 of Period 2 | |
| Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib | Day 1 of Period 1 and Day 5 of Period 2 | |
| Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib | Day 1 of Period 1 and Day 5 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period. |
|
| D010879 |
| Piperazines |