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The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.
This will be a 4-part study, with each part being an open-label fixed-sequence evaluation conducted in healthy adult participants. Approximately 64 participants will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants will receive a single dose of midazolam followed by multiple doses of GDC-0853 coadministered with a single dose of midazolam. |
|
| Part 2 | Experimental | Participants will receive a single dose of rosuvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of rosuvastatin. |
|
| Part 3 | Experimental | Participants will receive a single dose of simvastatin followed by multiple doses of GDC-0853 coadministered with a single dose of simvastatin. |
|
| Part 4 | Experimental | Participants will receive a single dose of GDC-0853 followed by multiple doses of itraconazole coadministered with a single dose of GDC-0853. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Single dose midazolam |
| |
| GDC-0853 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Cmax for midazolam (Part 1), rosuvastatin (Part 2), and simvastatin (Part 3) in the presence and absence of GDC-0853 and Cmax for GDC-0853 (Part 4) in the presence and absence of itraconazole. | Part 1: Pre-dose, 0.5 up to 48 hours post-dose Days 1, 9. Part 2: pre-dose, 0.5 up to 96 hours post-dose Days 1, 12. Part 3: pre-dose, 0.5 up to 48 hours post-dose on Days 1, 9. Part 4: pre-dose, 0.5 up to 48 hours post-dose Days 1, 10 |
| Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) | AUC0-t for midazolam (Part 1), rosuvastatin (Part 2), and simvastatin (Part 3) in the presence and absence of GDC-0853 and AUC0-t for GDC-0853 (Part 4) in the presence and absence of itraconazole. | Part 1: Pre-dose, 0.5 up to 48 hours post-dose Days 1, 9. Part 2: pre-dose, 0.5 up to 96 hours post-dose Days 1, 12. Part 3: pre-dose, 0.5 up to 48 hours post-dose on Days 1, 9. Part 4: pre-dose, 0.5 up to 48 hours post-dose Days 1, 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest (AESIs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AESIs include any serious infection, any infections requiring intravenous antimicrobials, and any opportunistic infections; bleeding events of moderate or greater severity; a laboratory result of aspartate aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or an AST or ALT > 3 × ULN in combination with a total bilirubin > 2 × ULN, of which at least 35% is direct bilirubin or there is clinical jaundice; cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; or suspected transmission of an infectious agent by the study drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Research Unit - Daytona | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Unit Inc.; Covance Gfi Research |
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| Drug |
Multiple doses GDC-0853 for 6 days |
|
| Midazolam and GDC-0853 | Drug | Multiple doses GDC-0853 and single dose midazolam |
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| Rosuvastatin | Drug | Single dose rosuvastatin |
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| Rosuvastatin and GDC-0853 | Drug | Multiple doses GDC-0853 and single dose rosuvastatin |
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| Simvastatin | Drug | Single dose simvastatin |
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| Simvastatin and GDC-0853 | Drug | Multiple doses GDC-0853 and single dose simvastatin |
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| GDC-0853 | Drug | Single dose GDC-0853 |
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| Itraconazole | Drug | Multiple doses itraconazole for 6 days |
|
| GDC-0853 and itraconazole | Drug | Multiple doses itraconazole and single dose GDC-0853 |
|
| Up to approximately 7 weeks |
| Cmax | Cmax for GDC-0853 (Parts 2 and 3) in the presence and absence of rosuvastatin and simvastatin, respectively, and Cmax for itraconazole (Part 4) in the presence and absence of GDC-0853. | 0.5 up to 12 hours post-dose on Days 11 and 12 |
| AUC0-12 | AUC0-12 for GDC-0853 (Parts 2 and 3) in the presence and absence of rosuvastatin and simvastatin, respectively, and AUC0-12 for itraconazole (Part 4) in the presence and absence of GDC-0853. | 0.5 up to 12 hours post-dose on Days 11 and 12 |
| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance Clinical Research Unit, Inc | Madison | Wisconsin | 53704 | United States |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000619415 | fenebrutinib |
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010879 | Piperazines |
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