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

A Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Lumacaftor	tablet, 200mg taken every 12 hours
DRUG	Ivacaftor	tablet, 250mg taken every 12 hours
DRUG	Ciprofloxacin	750 mg taken every 12 hours
DRUG	Itraconazole	200mg taken once daily
DRUG	Rifampin	600mg taken once daily

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• First posted: 2013-01-15
• Last updated: 2013-11-15

Locations

1 site across 1 country: United States