Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers (ABBV-576 DDI)

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    60
  • sponsor
    AbbVie
Updated on 21 October 2022
Accepts healthy volunteers

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.

Details
Condition Healthy Volunteers
Treatment Midazolam, Galicaftor, Navocaftor, ABBV-576
Clinical Study IdentifierNCT05530278
SponsorAbbVie
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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