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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral
Oral
Clinical Pharmacology of Miami /ID# 249531
Miami, Florida, United States
Acpru /Id# 249532
Grayslake, Illinois, United States
Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Time frame: Up to Day 4
Time to Cmax (peak time, Tmax)
Tmax will be assessed.
Time frame: Up to Day 4
Terminal Elimination Half-life (t1/2)
Terminal elimination half-life (t1/2) will be assessed.
Time frame: Up to Day 4
Area under the plasma curve (AUC)
AUC will be assessed.
Time frame: Up to Day 4
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Day 38
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