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

Last updated: January 17, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Venetoclax

Clinical Study ID

NCT06742086
M25-277
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) is 18.0 to 32.0 kg/m^2.

  • Must either be: postmenopausal, permanently surgically sterile, or perimenopausal orpremenopausal and practicing a method of birth control until at least 30 days afterthe last dose of study drug.

  • Have CD19+ B-cell count > 150 cells/μL at screening.

Exclusion

Exclusion Criteria:

  • History: of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic,cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in theoption of the investigator would adversely affect her participating in this study.

  • History of any clinically significant sensitivity or allergy to any medication orfood.

  • History of or active medical condition(s) or surgical procedure(s) that might affectgastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease,gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy forpyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Venetoclax
Phase: 1
Study Start date:
December 19, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Acpru /Id# 272979

    Grayslake, Illinois 60030
    United States

    Active - Recruiting

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