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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT06742086

Run by

AbbVie

People needed

72

Starts

2024-12-19

Expected to finish

2025-10-08

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.].

Where it is running

• Acpru /Id# 272979 — Grayslake, Illinois, United States
• PPD Phase I Clinic /ID# 275754 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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