A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05538585

Run by

AbbVie

People needed

24

Starts

2022-09-27

Expected to finish

2022-12-21

Last updated by the study team

2023-01-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Clinical Pharmacology of Miami /ID# 249531 — Miami, Florida, United States
• Acpru /Id# 249532 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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