A Dose-Escalation Safety And Pharmacokinetics/Pharmacodynamics (PK/PD) Study Of Macimorelin(Macrilen) In Pediatric Patients Atleast Three Years Old

Trial Profile

A Dose-Escalation Safety And Pharmacokinetics/Pharmacodynamics (PK/PD) Study Of Macimorelin(Macrilen) In Pediatric Patients Atleast Three Years Old

Planning
Phase of Trial: Phase I

Latest Information Update: 30 Mar 2017

At a glance

  • Drugs Macimorelin (Primary)
  • Indications Somatotropin deficiency
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 30 Mar 2017 New trial record
    • 07 Mar 2017 According to an Aeterna Zentaris media release, the Pediatric Committee (PDCO) of the European Medicines Agency agreed to Aeterna Zentaris Pediatric Investigation Plan (PIP) and also agreed that the company may defer conducting the studies defined in the PIP until it files an MAA for Macimorelin for the treatment of somatotropin-deficiency in adults.
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