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
Price :
$35
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At a glance
- Drugs Macimorelin (Primary)
- Indications Somatotropin deficiency
- Focus Adverse reactions
- Sponsors AEterna Zentaris GmbH
- 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.