NCT02349503

Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia

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 Hyperplasia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: Female
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	NBI-77860
DRUG	NBI-77860
DRUG	NBI-77860

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-01-29
• Last updated: 2015-06-11

Locations

2 sites across 1 country: United States