A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants

Phase 1

Not yet recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Body mass index (BMI) is 18.0 to 32.0 kg/m^2.
Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 30 days after the last dose of study drug.
Have CD19+ B-cell count > 150 cells/μL at screening.

Exclusion Criteria

History: of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in the option of the investigator would adversely affect her participating in this study.
History of any clinically significant sensitivity or allergy to any medication or food.
History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

Arm && Interventions

Group	Intervention	Description
Stage 1: Sequence 1: Venetoclax	Venetoclax	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.
Stage 1: Sequence 2: Venetoclax	Venetoclax	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.
Stage 1: Sequence 3: Venetoclax	Venetoclax	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.
Stage 2: Sequence 1: Venetoclax	Venetoclax	Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.
Stage 2: Sequence 2: Venetoclax	Venetoclax	Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.
Stage 2: Sequence 3: Venetoclax	Venetoclax	Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AE)	Up to Approximately 18 Months	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.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)	Up to Approximately 18 Months	Cmax of venetoclax HME-03.
Time to Cmax (Tmax) of Venetoclax HME-03	Up to Approximately 18 Months	Tmax of venetoclax HME-03.
Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03	Up to Approximately 18 Months	β of venetoclax HME-03.
Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03	Up to Approximately 18 Months	t1/2 of venetoclax HME-03.
Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03	Up to Approximately 18 Months	AUCt of venetoclax HME-03.
Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03	Up to Approximately 18 Months	AUCinf of venetoclax HME-03.

Secondary Outcome Measures

Name	Time	Method