A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco

Trial Profile

A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2015

At a glance

  • Drugs Ivacaftor deuterated (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Concert Pharmaceuticals
  • Most Recent Events

    • 05 Nov 2015 According to a Concert Pharmaceuticals media release, results from this trial were presented at the Cystic Fibrosis UK Trust Conference and the North American Cystic Fibrosis Conference.
    • 22 Sep 2015 The data from this trial will be presented in the poster session at the North American Cystic Fibrosis Conference, according to a Concert Pharmaceuticals media release.
    • 22 Sep 2015 Results published in a Concert Pharmaceuticals media release.
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