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Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD)

Trial Profile

Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 May 2021

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At a glance

  • Drugs Macimorelin (Primary)
  • Indications Somatotropin deficiency
  • Focus Adverse reactions
  • Sponsors AEterna Zentaris GmbH
  • Most Recent Events

    • 23 Mar 2021 Results presented at the 103rd Annual Meeting of the Endocrine Society
    • 16 Sep 2020 According to an AEterna Zentaris Inc media release, the positive dose-finding results from this study provide the clinical framework for Study P02 and establish a dose that could both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD.
    • 08 Sep 2020 According to an AEterna Zentaris Inc media release, results from this trial were presented at the 22nd European Congress of Endocrinology (e-ECE 2020), being held September 5-9, 2020.
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