Not provided
Not provided
Not provided
Not provided
Not provided
Strategic considerations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Participants will receive venetoclax dose A commercial formulation following a high-fat meal. |
|
| Regimen B | Experimental | Participants will receive venetoclax dose B new formulation following a high-fat meal. |
|
| Regimen C | Experimental | Participants will receive venetoclax dose A new formulation following a high-fat meal. |
|
| Regimen D | Experimental | Participants will receive venetoclax dose B new formulation under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral; Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Venetoclax | Cmax of Venetoclax will be assessed. | Up to Day 27 |
| Time to Cmax (Tmax) of Venetoclax | Tmax of Venetoclax will be assessed. | Up to Day 27 |
| Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax | AUCt of Venetoclax will be assessed. | Up to Day 27 |
| AUC from Time 0 to Infinity (AUCinf) of Venetoclax | AUCinf of Venetoclax will be assessed. | Up to Day 27 |
| Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax | Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed. | Up to Day 27 |
| Terminal Phase Elimination Half-life (t1/2) of Venetoclax | Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed. | Up to Day 27 |
| Number of Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 57 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 259897 | Grayslake | Illinois | 60030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided