Status:
COMPLETED
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Lead Sponsor:
Richard Barry Moss
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Cystic fibrosis (CF) is a genetic disease caused by malfunctioning of a protein called CFTR. CF affects various organs including the sweat glands and the lungs. An FDA approved drug called ivacaftor ...
Eligibility Criteria
Inclusion
- Healthy adults without a Cystic Fibrosis (CF) mutation
- Carriers with a known CF mutation
Exclusion
- 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.
Key Trial Info
Start Date :
July 31 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02310789
Start Date
July 31 2015
End Date
August 23 2017
Last Update
January 9 2019
Active Locations (1)
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1
Stanford Hospital and Clinics
Stanford, California, United States, 94305