A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
- Registration Number
- NCT05538585
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Navocaftor without food Navocaftor Participants will receive navocaftor administered without food Part 1: Navocaftor with food Navocaftor Participants will receive navocaftor administered with food Part 2: Galicaftor without food Galicaftor Participants will receive galicaftor administered without food Part 2: Galicaftor with food Galicaftor Participants will receive galicaftor administered with food
- Primary Outcome Measures
Name Time Method Terminal Elimination Half-life (t1/2) Up to Day 4 Terminal elimination half-life (t1/2) will be assessed.
Time to Cmax (peak time, Tmax) Up to Day 4 Tmax will be assessed.
Number of Participants with Adverse Events (AEs) Up to Day 38 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.
Area under the plasma curve (AUC) Up to Day 4 AUC will be assessed.
Maximum Observed Plasma Concentration (Cmax) Up to Day 4 Cmax will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Clinical Pharmacology of Miami /ID# 249531
🇺🇸Miami, Florida, United States
Acpru /Id# 249532
🇺🇸Grayslake, Illinois, United States