Trials / Completed
CompletedNCT05538585
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Galicaftor | Oral |
| DRUG | Navocaftor | Oral |
Timeline
- Start date
- 2022-09-27
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
- First posted
- 2022-09-14
- Last updated
- 2023-01-17
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05538585. Inclusion in this directory is not an endorsement.