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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Navocaftor with food | Experimental | Participants will receive navocaftor administered with food |
|
| Part 1: Navocaftor without food | Experimental | Participants will receive navocaftor administered without food |
|
| Part 2: Galicaftor with food | Experimental | Participants will receive galicaftor administered with food |
|
| Part 2: Galicaftor without food | Experimental | Participants will receive galicaftor administered without food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galicaftor | Drug | Oral |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami /ID# 249531 | Miami | Florida | 33014 | United States | ||
| Acpru /Id# 249532 |
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| ID | Term |
|---|---|
| C000708865 | GLPG2222 |
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| Navocaftor | Drug | Oral |
|
|
| Grayslake |
| Illinois |
| 60030 |
| United States |