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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)

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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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