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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 rifampin 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 Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8. |
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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 8 of Period 2 | |
| Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib | Day 1 of Period 1 and Day 8 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 8 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to Week 14 |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Dallas CRU | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug | Rifampin will be administered QD on Days 1 to 7 and Days 9 to 13 and as a single oral dose on Day 8 as specified for the respective period. |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |