A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

Completed · Phase 1

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01899105

Run by

Vertex Pharmaceuticals Incorporated

People needed

28

Starts

2013-07-01

Expected to finish

2013-08-01

Last updated by the study team

2014-04-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects as defined in the protocol
• Subjects who weigh >50 kg at Screening

You may not qualify if…

• History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
• Standard 12-lead ECG demonstrating QTc >450 msec for male subjects and >480 msec for female subjects at the Screening Visit
• Abnormal renal function as defined in the protocol at Screening
• Forced expiratory volume in 1 second (FEV1) <80% predicted at the Screening Visit
• Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug
• Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug

Where it is running

• Study site — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.