A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis

Study Identifier
M20-974
CT.gov Identifier
NCT05530278
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • Galicaftor
  • ABBV-576
  • Navocaftor
  • Midazolam
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 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).
    Exclusion Criteria:
    * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * History of any clinically significant condition listed in the protocol.

    Protocol Summary

    Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.

    Study Locations

    Location
    Status
    Location
    Anaheim Clinical Trials LLC /ID# 248824
    Anaheim, California, United States, 92801-2658
    Status
    Not applicable
    Location
    Clinical Pharmacology of Miami /ID# 248823
    Miami, Florida, United States, 33014
    Status
    Not applicable
    Location
    PPD Clinical Research Unit -Las Vegas /ID# 248853
    Las Vegas, Nevada, United States, 89113-2235
    Status
    Not applicable
    Location
    PPD Clinical Research Unit - Austin /ID# 248854
    Austin, Texas, United States, 78744
    Status
    Not applicable