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The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Sequence 1 | Experimental | Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period. |
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| Venetoclax Sequence 2 | Experimental | Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period. |
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| Venetoclax Sequence 3 | Experimental | Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral; Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 75 Days |
| Maximum Observed Plasma Concentration (Cmax) of Venetoclax | Cmax of venetoclax. | Up to 45 Days |
| Time to Cmax (Tmax) of Venetoclax | Tmax of venetoclax. | Up to 45 Days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax | AUCt of venetoclax. | Up to 45 Days |
| AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax | AUCinf of venetoclax. | Up to 45 Days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax | Apparent terminal phase elimination rate constant of venetoclax. | Up to 45 Days |
| Terminal Phase Elimination Half-life (t1/2) of Venetoclax | T1/2 of venetoclax. | Up to 45 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 255783 | Grayslake | Illinois | 60030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38782609 | Derived | Alaei S, Wang Y, Liu Y, Schiele J, Deng R, Shiller D, Marroum P, Menon R, Salem AH. Venetoclax Clinical Pharmacokinetics After Administration of Crushed, Ground or Whole Tablets. Clin Ther. 2024 Oct;46(10):752-758. doi: 10.1016/j.clinthera.2024.03.012. Epub 2024 May 22. |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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