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

NCT06742086 | Completed Phase 1

• 1 other identifier: M25-277
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Venetoclax; ABT-199; Venclexta; Venclyxto

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (6)

Stage 1: Sequence 1: Venetoclax

EXPERIMENTAL

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

Stage 1: Sequence 2: Venetoclax

EXPERIMENTAL

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

Stage 1: Sequence 3: Venetoclax

EXPERIMENTAL

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

Stage 2: Sequence 1: Venetoclax

EXPERIMENTAL

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

Stage 2: Sequence 2: Venetoclax

EXPERIMENTAL

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

Stage 2: Sequence 3: Venetoclax

EXPERIMENTAL

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

Interventions

Venetoclax DRUG

Oral Tablet

Also known as: ABT-199, Venclexta, Venclyxto

Stage 1: Sequence 1: Venetoclax; Stage 1: Sequence 2: Venetoclax; Stage 1: Sequence 3: Venetoclax; Stage 2: Sequence 1: Venetoclax; Stage 2: Sequence 2: Venetoclax; Stage 2: Sequence 3: Venetoclax

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Acpru /Id# 272979

Grayslake, Illinois, 60030, United States

Location

PPD Phase I Clinic /ID# 275754

Austin, Texas, 78744, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

venetoclax

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 19, 2024
• Study Start: December 19, 2024
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)