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This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive a single oral dose of Digoxin and Rosuvastatin drug cocktail. |
|
| Treatment B | Experimental | Participants will receive a single dose of Digoxin and Rosuvastatin drug cocktail administered 2 hours after the Divarasib dose on Day 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Digoxin will be administered together with Rosuvastatin as a drug cocktail as specified for the respective period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin | Day 1 of Period 1 and Day 5 of Period 2 | |
| Area Under the Plasma Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Digoxin and Rosuvastatin | Day 1 of Period 1 and Day 5 of Period 2 | |
| Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin | Day 1 of Period 1 and Day 5 of Period 2 | |
| Time to Cmax (Tmax) of Digoxin and Rosuvastatin | Day 1 of Period 1 and Day 5 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | From Day 1 until end of study participation (approximately 2 months) |
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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 |
|---|---|---|---|---|---|---|
| Daytona Beach Clinical Rsch Unit | Daytona Beach | Florida | 32117 | United States |
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| Divarasib | Drug | Divarasib will be administered in combination with Digoxin and Rosuvastatin as specified for the respective period |
|
| Rosuvastatin | Drug | Rosuvastatin will be administered together with Digoxin as a drug cocktail as specified for the respective period |
|
| ID | Term |
|---|---|
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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