Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macimorelin in Children with Suspected Growth Hormone Deficiency: An Open-Label, Group Comparison, Dose-Escalation Trial.

Violetta Csákváry,Nicola Ammer, Ekaterine Bakhtadze Bagci, Olena V Bolshova,Birgitte Bentz Damholt,Dragan Katanic, Evgenia Mikhailova,Ágota Muzsnai,Dmitri Raduk,Ganna Senatorova,Mieczysław Szalecki,Michael Teifel, Zsolt Vajda,Nataliya Zelinska,Tetyana Chaychenko

Hormone research in paediatrics（2021）

Cited 8|Views5

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Abstract

All 3 doses of macimorelin had excellent safety and tolerability with PK/PD profiles in expected ranges. These results support the use of 1.0 mg/mL macimorelin in a Phase 3 test validation trial in children.

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Key words

Drug safety,Drug tolerance,Growth hormone deficiency,Macimorelin,Paediatrics,Pharmacodynamics,Pharmacokinetics,Tolerability

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