(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results. To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil. The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.

Key facts

Study ID

NCT02310789

Run by

Richard Barry Moss

People needed

8

Starts

2015-07-31

Expected to finish

2017-08-23

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults without a Cystic Fibrosis (CF) mutation
• Carriers with a known CF mutation

You may not qualify if…

• Documented liver disease
• Participants should not be taking:
• medicines that are strong CYP3A (Cytochrome P450, family 3, subfamily A) inducers, such as:
• the antibiotics rifampin and rifabutin;
• seizure medications (phenobarbital, carbamazepine, or phenytoin); and
• the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor and may diminish effectiveness.

Where it is running

• Stanford Hospital and Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

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