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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT06742086

M25-277

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 6 patient groups

Stage 1: Sequence 1: Venetoclax

Experimental group

Description:

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.

Treatment:

Drug: Venetoclax

Stage 1: Sequence 2: Venetoclax

Experimental group

Description:

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.

Treatment:

Drug: Venetoclax

Stage 1: Sequence 3: Venetoclax

Experimental group

Description:

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.

Treatment:

Drug: Venetoclax

Stage 2: Sequence 1: Venetoclax

Experimental group

Description:

Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.

Treatment:

Drug: Venetoclax

Stage 2: Sequence 2: Venetoclax

Experimental group

Description:

Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.

Treatment:

Drug: Venetoclax

Stage 2: Sequence 3: Venetoclax

Experimental group

Description:

Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.

Treatment:

Drug: Venetoclax