A Phase 1 interventional study of Galicaftor and Navocaftor in Healthy Volunteers, sponsored by AbbVie. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
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.
AbbVie is the lead sponsor of 969 studies on the registry; 134 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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Exclusion Criteria:
Participants will receive navocaftor administered with food
Drug: Navocaftor
Participants will receive navocaftor administered without food
Drug: Navocaftor
Participants will receive galicaftor administered with food
Drug: Galicaftor
Participants will receive galicaftor administered without food
Drug: Galicaftor
Oral
Also known as: ABBV-2222
Oral
Also known as: ABBV-3067
Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Time frame: Up to Day 4
Time to Cmax (peak time, Tmax)
Tmax will be assessed.
Time frame: Up to Day 4
Terminal Elimination Half-life (t1/2)
Terminal elimination half-life (t1/2) will be assessed.
Time frame: Up to Day 4
Area under the plasma curve (AUC)
AUC will be assessed.
Time frame: 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.
Time frame: Up to Day 38
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: GLPG2222 · Navocaftor