A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor. (M23-492 FE)

  • STATUS
    Recruiting
  • days left to enroll
    50
  • participants needed
    24
  • sponsor
    AbbVie
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Updated on 23 October 2022
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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 objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.

Details
Condition Healthy Volunteers
Treatment Galicaftor, Navocaftor
Clinical Study IdentifierNCT05538585
SponsorAbbVie
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Body Mass Index (BMI) is => 18.0 to <= 32.0 kg/ m2 after rounding to the tenth's 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 or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.]
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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