Evaluating a new tablet formulation of venetoclax in healthy women
A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects
PHASE1 · AbbVie · NCT06742086
This study is testing a new tablet version of venetoclax in healthy women to see how well it works with food compared to the current version.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | AbbVie (industry) |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT06742086 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the bioavailability of a new high drug load formulation of venetoclax in healthy adult female participants. It will compare the new tablet formulation to the existing commercial version under high-fat dietary conditions. The study will also evaluate how food intake affects the absorption of the new formulation at its highest dosage strength. Participants will be closely monitored to ensure their health and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult females with a BMI between 18.0 and 32.0 kg/m² who meet specific reproductive criteria.
Not a fit: Patients with a history of significant medical conditions or gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved formulations of venetoclax that enhance its effectiveness and absorption in patients.
How similar studies have performed: Other studies evaluating the bioavailability of drug formulations have shown promise, but this specific formulation approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 272979 — Grayslake, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: ABBVIE CALL CENTER
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteer, Venetoclax, ABT-199, Venclexta, Venclyxto