Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
00
Trial Sponsor
Clinical Trial Start Date
2015
0Primary Completion Date
2015
0Study Completion Date
2015
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
NBI-778600
Interventional Trial Phase
Phase 10
Official Name
A Phase 1, Open-Label, Single-Dose, Sequential Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia0
Last Updated
June 11, 2015
0Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.
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