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The objective of this study is to assess the bioavailability (BA) of venetoclax new high drug load hot melt extrusion-03 (HME-03) tablet formulation at two different tablet strengths relative to the commercial venetoclax tablet formulation under high-fat conditions in healthy female volunteers. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Sequence 1: Venetoclax | Experimental | Participants will receive commercial venetoclax following a high-fat meal (Regimen A), followed by venetoclax hot melt extrusion-03 (HME-03) dose A following a high-fat meal (Regimen B), followed by venetoclax HME-03 dose B following a high-fat meal (Regimen C), finally followed by venetoclax HME-03 dose A following fasting (Regimen D), as part of the approximately 18 month study duration. |
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| Stage 1: Sequence 2: Venetoclax | Experimental | Participants will receive Regimen B, followed by Regimen C, followed by Regimen A, finally followed by Regimen D, as part of the approximately 18 month study duration. |
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| Stage 1: Sequence 3: Venetoclax | Experimental | Participants will receive Regimen C, followed by Regimen A, followed by Regimen B, finally followed by Regimen D, as part of the approximately 18 month study duration. |
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| Stage 2: Sequence 1: Venetoclax | Experimental | Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration. |
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| Stage 2: Sequence 2: Venetoclax | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Approximately 18 Months |
| Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03) | Cmax of venetoclax HME-03. | Up to Approximately 18 Months |
| Time to Cmax (Tmax) of Venetoclax HME-03 | Tmax of venetoclax HME-03. | Up to Approximately 18 Months |
| Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03 | β of venetoclax HME-03. | Up to Approximately 18 Months |
| Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03 | t1/2 of venetoclax HME-03. | Up to Approximately 18 Months |
| Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03 | AUCt of venetoclax HME-03. | Up to Approximately 18 Months |
| Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03 | AUCinf of venetoclax HME-03. | Up to Approximately 18 Months |
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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# 272979 | Grayslake | Illinois | 60030 | United States | ||
| PPD Phase I Clinic /ID# 275754 |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration. |
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| Stage 2: Sequence 3: Venetoclax | Experimental | Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration. |
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| Austin |
| Texas |
| 78744 |
| United States |