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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000752-26 | EudraCT Number |
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The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: GDC-0853 (Effect of Formulation) | Experimental | Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state. |
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| Part 2: GDC-0853 (Effect of Food and Rabeprazole) | Experimental | Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization. |
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| Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole) | Experimental | Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0853 | Drug | Participants will receive different formulations of GDC-0853 tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Apparent Terminal Elimination Rate Constant of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Apparent Volume of Distribution (Vz/F) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Apparent Oral Clearance (CL/F) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part | |
| Relative Bioavailability (Frel) of GDC-0853 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | From screening to the end of the study (approximately a maximum of 11 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd, Clinical Research Unit | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853. |
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| Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part |
| Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853 | Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |