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

Study Identifier
M25-277
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
  • Study Drug
  • Venetoclax
  • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 65 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 272979
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable
    Location
    PPD Phase I Clinic /ID# 275754
    Austin, Texas, United States, 78744
    Status
    Not applicable