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Completed

NCT Number: NCT06742086

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 272979, Grayslake, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.].

Treatment and study plan

Venetoclax

Drug

Oral Tablet

Other names: ABT-199, Venclexta, Venclyxto

Primary outcomes

  1. Number of Participants with Adverse Events (AE)

    Time frame: Up to Approximately 18 Months

    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.

  2. Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)

    Time frame: Up to Approximately 18 Months

    Cmax of venetoclax HME-03.

  3. Time to Cmax (Tmax) of Venetoclax HME-03

    Time frame: Up to Approximately 18 Months

    Tmax of venetoclax HME-03.

  4. Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03

    Time frame: Up to Approximately 18 Months

    β of venetoclax HME-03.

  5. Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03

    Time frame: Up to Approximately 18 Months

    t1/2 of venetoclax HME-03.

  6. Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03

    Time frame: Up to Approximately 18 Months

    AUCt of venetoclax HME-03.

  7. Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03

    Time frame: Up to Approximately 18 Months

    AUCinf of venetoclax HME-03.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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