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This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Sequence 4 | Experimental |
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| Sequence 5 | Experimental |
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| Sequence 6 | Experimental |
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| Sequence 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-A-1041 Formulation 1 | Drug | Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Days 1 to 8, 11 to 14, and 17 to 20 | |
| Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) | Days 1 to 8, 11 to 14, and 17 to 20 | |
| AUC Extrapolated to Infinity (AUC0-∞) | Days 1 to 8, 11 to 14, and 17 to 20 | |
| Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞ | Days 1 to 8, 11 to 14, and 17 to 20 |
| Measure | Description | Time Frame |
|---|---|---|
| ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments | Days 1 to 8, 11 to 14, and 17 to 20 | |
| ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments | Days 1 to 8, 11 to 14, and 17 to 20 |
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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 |
|---|---|---|---|---|---|---|
| Daytona Beach Clinical Rsch Unit | Daytona Beach | Florida | 32117 | United States | ||
| Fortrea Clinical Research Unit - Dallas |
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| Sequence 8 | Experimental |
|
| ZN-A-1041 Formulation 2 | Drug | Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment. |
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| Rabeprazole | Drug | Participants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17. |
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| ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments | Days 1 to 8, 11 to 14, and 17 to 20 |
| ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments | Days 1 to 8, 11 to 14, and 17 to 20 |
| ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments | Days 1 to 8, 11 to 14, and 17 to 20 |
| Incidence of Adverse Events (AEs), Including Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | Up to approximately 8.5 weeks |
| Severity of AEs, Including SAEs and AESIs | Up to approximately 8.5 weeks |
| Number of Participants with Abnormalities in Clinical Laboratory Results | Baseline, Days 2, 4, 6, 10, 16, and 20 |
| Changes from Baseline in Oral Temperature Measurements | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Columbia Suicide Severity Rating Scale (C-SSRS) Questionnaires | Baseline, Day 1, 5, 11, 17, and 20 |
| Changes from Baseline in Respiratory Rate Measurements | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in Systolic Blood Pressure Measurements | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in Pulse Rate Measurements | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in Diastolic Blood Pressure Measurements | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration) | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in 12-lead ECG Parameters (Heart Rate) | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in 12-lead ECG Parameters (Sinus Rhythm) | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Changes from Baseline in 12-lead ECG Parameters (QTcF) | Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20 |
| Dallas |
| Texas |
| 75247-4989 |
| United States |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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