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This is a Phase 1, open-label, randomized, two-part study to evaluate the relative bioavailability (rBA) of two tablet formulations compared to the capsule formulation of ZN-A-1041 (Part 1). Part 2 of the study will evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation. No participants were enrolled in Part 2 of the study as it has been cancelled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ZN-A-1041 | Experimental | Participants will be administered a single dose of ZN-A-1041 orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-A-1041 | Drug | Participants will be administered either a ZN-A-1041 capsule or a tablet orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Days 1-12 (Part 1) | |
| Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t) | Days 1-12 (Part 1) | |
| AUC Extrapolated to Infinity (AUC0-inf) | Days 1-12 (Part 1) | |
| Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax | Days 1-12 (Part 1) | |
| Geometric Mean Ratio and Associated 90% CI of AUC0-t | Days 1-12 (Part 1) | |
| Geometric Mean Ratio and Associated 90% CI of AUC0-inf | Days 1-12 (Part 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Concentration (tmax) | Days 1-12 (Part 1) | |
| Apparent Terminal Elimination Rate Constant | Days 1-12 (Part 1) | |
| Apparent Terminal Elimination Half-Life (t1/2) |
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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 Leeds CRU | Leeds | LS11 9EH | United Kingdom |
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| Days 1-12 (Part 1) |
| Apparent Systemic Clearance (CL/F) | Days 1-12 (Part 1) |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Days 1-12 (Part 1) |
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 16 days |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, days 1, 5, 9 and 12 (Part 1) |