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

Study Overview
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Brief Summary
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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.

Official Title
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A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Galicaftor
* Drug: Navocaftor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Navocaftor with food<br>Participants will receive navocaftor administered with food | Drug: Navocaftor<br>* Oral<br>* Other names: ABBV-3067;|
| Experimental: Part 1: Navocaftor without food<br>Participants will receive navocaftor administered without food | Drug: Navocaftor<br>* Oral<br>* Other names: ABBV-3067;|
| Experimental: Part 2: Galicaftor with food<br>Participants will receive galicaftor administered with food | Drug: Galicaftor<br>* Oral<br>* Other names: ABBV-2222;|
| Experimental: Part 2: Galicaftor without food<br>Participants will receive galicaftor administered without food | Drug: Galicaftor<br>* Oral<br>* Other names: ABBV-2222;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | Cmax will be assessed. | Up to Day 4 | 
| Time to Cmax (peak time, Tmax) | Tmax will be assessed. | Up to Day 4 | 
| Terminal Elimination Half-life (t1/2) | Terminal elimination half-life (t1/2) will be assessed. | Up to Day 4 | 
| Area under the plasma curve (AUC) | AUC will be assessed. | 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. | Up to Day 38 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Galicaftor, Navicaftor, ABBV-3067, ABBV-2222