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

A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Venetoclax

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 272979
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic /ID# 275754

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto
Experimental: 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.	Drug: Venetoclax; Oral Tablet; Other Names: Venclexta; ABT-199; Venclyxto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 18 Months
Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)	Cmax of venetoclax HME-03.	Up to Approximately 18 Months
Time to Cmax (Tmax) of Venetoclax HME-03	Tmax of venetoclax HME-03.	Up to Approximately 18 Months
Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03	β of venetoclax HME-03.	Up to Approximately 18 Months
Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03	t1/2 of venetoclax HME-03.	Up to Approximately 18 Months
Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03	AUCt of venetoclax HME-03.	Up to Approximately 18 Months
Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03	AUCinf of venetoclax HME-03.	Up to Approximately 18 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): October 8, 2025
• Study Completion (Actual): October 8, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Venetoclax; ABT-199; Venclexta; Venclyxto
• Additional Relevant MeSH Terms: Antineoplastic Agents; venetoclax
• Other Study ID Numbers: M25-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes