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Drug & research development » Clinical trials » NCT02310789

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

Official 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

Clinical Trials gov number: NCT02310789

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Purpose: To access the effects of ivacaftor on wild type CFTR-open probability (PO) in the sweat gland secretory coil

Phase: 1

Type: Interventional, non-randomized, open-label, single group assignment

Study sponsor: Richard Barry Moss; Stanford University

  • Healthy adults without a cystic fibrosis (CF) mutation
  • Carriers with a known CF mutation


Geographical Location
United States

Number of Participants
≤50 (≥18 years)

Primary Endpoint

CFTR-dependent sweat rate (21-35 days per subject)

Secondary Endpoint

  • Sweat chloride concentration (21-35 days per subject)

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  • Experimental: Ivacaftor Use

Diagnostic testing to be performed on Ivacaftor 150mg Q12 p.o. Protocol describes Ivacaftor treatment to be given in two-week intervals. The patient will serve as their own controls. Diagnostic procedures to be performed on and off Ivacaftor.

  • No Intervention: Off Ivacaftor

Patients will be off drug and the same diagnostic procedures will be done during both periods. Therefore, patients are acting as their own controls in this crossover study.

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