Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia
Status:
Withdrawn
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and
tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with
congenital adrenal hyperplasia (CAH). The study will be conducted in approximately 15
adolescent females (12-18 years of age) with a documented medical diagnosis of classic
21-hydroxylase deficiency CAH. The study will include three independent dose cohorts of
NBI-77860 (approximately 5 subjects per dose cohort). Ascending doses will be evaluated as
part of a sequential-cohort design.