A Phase 1 interventional study of Lumacaftor and Ivacaftor in Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-15.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment
The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 80 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and ciprofloxacin through Day 21.
Drug: Lumacaftor · Drug: Ivacaftor · Drug: Ciprofloxacin
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and itraconazole through Day 21.
Drug: Lumacaftor · Drug: Ivacaftor · Drug: Itraconazole
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and rifampin through Day 24.
Drug: Lumacaftor · Drug: Ivacaftor · Drug: Rifampin
Subjects will take a single dose of lumacaftor in combination with ivacaftor on 3 occasions separated by 7 days.
Drug: Lumacaftor · Drug: Ivacaftor
tablet, 200mg taken every 12 hours
Also known as: VX-809
tablet, 250mg taken every 12 hours
Also known as: VX-770
750 mg taken every 12 hours
200mg taken once daily
600mg taken once daily
Cohorts 1-3: PK parameters including Cmax, and AUC from time of dosing to time tau of lumacaftor and ivacaftor in the absence and presence of ciprofloxacin, itraconazole, and rifampin
Time frame: up to 24 days
Cohort 4: Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor.
Time frame: up to 21 days
Cohorts 1-4: Safety and tolerability as measured by adverse events (AEs) and changes in laboratory test values (serum chemistry, hematology, coagulation, and urinalysis), vital signs, standard 12 lead electrocardiograms (ECGs), and spirometry
Time frame: up to 31 days
Cohort 4: PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function
Time frame: 16 days
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated