Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia

CAH - Congenital Adrenal Hyperplasia Clinical Trial

Official title: A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia

Status Completed

Clinical Trial Summary

This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in approximately 12 pediatric female and male subjects (14 to 17 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• CAH - Congenital Adrenal Hyperplasia
• Hyperplasia

• NCT number: NCT04045145
• Study type: Interventional
• Source: Neurocrine Biosciences
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2019
• Completion date: July 2, 2021