A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Multiple Oral Doses of SHP626 in Overweight and Obese Adult Subjects

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Multiple Oral Doses of SHP626 in Overweight and Obese Adult Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Dec 2016

At a glance

  • Drugs Volixibat (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Shire
  • Most Recent Events

    • 20 Jul 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 11 Mar 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record.
    • 12 Feb 2015 According to a Shire media release, an investigation new drug application was approved by FDA in the fourth quarter of 2014.
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