A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

Study Identifier
M22-457
CT.gov Identifier
NCT06070948
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • Venetoclax
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal. * A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG). * Participant must be postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.
    Exclusion Criteria:
    \- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

    Protocol Summary

    The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 259897
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable