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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02310789
Date of registration: 03/09/2014
Prospective Registration: Yes
Primary sponsor: Richard Barry Moss
Public title: (Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Scientific title: (Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory Coil
Date of first enrolment: July 31, 2015
Target sample size: 8
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02310789
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Jeffrey Wine, PhD
Address: 
Telephone:
Email:
Affiliation:  Stanford University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adults without a Cystic Fibrosis (CF) mutation

- Carriers with a known CF mutation

Exclusion Criteria:

1. Documented liver disease

2. 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Device: Macroduct sweat stimulator
Drug: Ivacaftor
Drug: Pilocarpine Nitrate 5%
Drug: ß-Adrenergic cocktail
Primary Outcome(s)
Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate [Time Frame: Up to 79 days]
Secondary Outcome(s)
Change Sweat Chloride Production [Time Frame: Up to 79 days]
Secondary ID(s)
31238
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 20/04/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02310789
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