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Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure

Trial Profile

Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Mar 2017

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At a glance

  • Drugs Cimaglermin alfa (Primary) ; Midazolam
  • Indications Acute coronary syndromes; Heart failure
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Acorda Therapeutics
  • Most Recent Events

    • 18 Mar 2017 Results (n=2) investigating cases of hepatotoxicity from two phase 1 trials (NCT01944683 and NCT01258387) meeting Hy's Law criteria, presented at the 118th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 12 Jul 2016 Status changed from active, no longer recruiting to completed.
    • 21 Dec 2015 Planned End Date changed from 1 Nov 2015 to 1 Jul 2016 as reported by ClinicalTrials.gov record.
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