Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
Status:
Completed
Trial end date:
2020-04-07
Target enrollment:
Participant gender:
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 up to 30 adult
female and male subjects (18 to 50 years of age) with a documented medical diagnosis of
classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The study will
include a sequential-cohort design with three NBI-74788 dose cohorts, with each dose
administered for 14 consecutive days. Cohort 3 will be conducted in parallel with cohort 2.