A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants
NCT ID: NCT06742086
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2024-12-19
2025-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stage 1: Sequence 1: 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.
Venetoclax
Oral Tablet
Stage 1: Sequence 2: 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.
Venetoclax
Oral Tablet
Stage 1: Sequence 3: 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.
Venetoclax
Oral Tablet
Stage 2: Sequence 1: Venetoclax
Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.
Venetoclax
Oral Tablet
Stage 2: Sequence 2: Venetoclax
Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.
Venetoclax
Oral Tablet
Stage 2: Sequence 3: Venetoclax
Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.
Venetoclax
Oral Tablet
Interventions
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Venetoclax
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
18 Years
65 Years
FEMALE
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Acpru /Id# 272979
Grayslake, Illinois, United States
PPD Phase I Clinic /ID# 275754
Austin, Texas, United States
Countries
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Related Links
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Other Identifiers
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M25-277
Identifier Type: -
Identifier Source: org_study_id
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