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| ID | Type | Description | Link |
|---|---|---|---|
| QSC302214 | Other Identifier | Quotient Sciences |
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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Phenytoin + Sonrotoclax | Experimental | Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants. |
|
| Part B: Itraconazole + Sonrotoclax | Experimental | Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenytoin | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax | Approximately 21 days for Part A and 11 days for Part B | |
| Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of Participants with Adverse Events (AEs) | Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments. | From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D010672 | Phenytoin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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| Itraconazole |
| Drug |
Administered orally. |
|
| sonrotoclax | Drug | Administered orally. |
|
|
| Approximately 21 days for Part A and 11 days for Part B |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D010879 | Piperazines |