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Safety Study of Ivacaftor in Subjects With Cystic Fibrosis

NCT00457821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-10-05

Study results available
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Summary

The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

Conditions

Interventions

DRUG

Ivacaftor 25 mg/75 mg

25 mg or 75 mg q12h for a total of 28 days (Part 1)

DRUG

Ivacaftor 75 mg/150 mg

75 mg or 150 mg q12h for a total of 28 days (Part 1)

DRUG

Ivacaftor 150 mg or 250 mg

150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2)

DRUG

Placebo

Given q12h for 28 days each in Part 1 and Part 2 of the study

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00457821 on ClinicalTrials.gov