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

Accepts 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)

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.