CLINICAL TRIALS PROFILE FOR IVACAFTOR; LUMACAFTOR
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All Clinical Trials for IVACAFTOR; LUMACAFTOR
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01225211 ↗ | Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | Completed | Vertex Pharmaceuticals Incorporated | Phase 2 | 2010-10-01 | The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation. |
| NCT01768663 ↗ | A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects | Completed | Vertex Pharmaceuticals Incorporated | Phase 1 | 2013-01-01 | 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. |
| NCT01807923 ↗ | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | Completed | Vertex Pharmaceuticals Incorporated | Phase 3 | 2013-05-01 | The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene. |
| NCT01807949 ↗ | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | Completed | Vertex Pharmaceuticals Incorporated | Phase 3 | 2013-04-01 | The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene. |
| NCT01888393 ↗ | Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects | Completed | Vertex Pharmaceuticals Incorporated | Phase 1 | 2013-06-01 | This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment. |
| NCT01897233 ↗ | Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Completed | Vertex Pharmaceuticals Incorporated | Phase 3 | 2013-07-01 | This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. |
| NCT01899105 ↗ | A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor | Completed | Vertex Pharmaceuticals Incorporated | Phase 1 | 2013-07-01 | This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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