Trials / Completed
CompletedNCT05530278
A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis
Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- 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 main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Galicaftor | Oral |
| DRUG | ABBV-576 | Oral |
| DRUG | Navocaftor | Oral |
| DRUG | Midazolam | Oral |
Timeline
- Start date
- 2022-09-20
- Primary completion
- 2022-11-29
- Completion
- 2022-11-29
- First posted
- 2022-09-07
- Last updated
- 2023-02-21
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05530278. Inclusion in this directory is not an endorsement.