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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

Intervention
Ivacaftor

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.

View Trial Results