NCT04045145

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• CAH - Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Crinecerfont	Crinecerfont administered orally for 14 consecutive days.

Timeline

• Start date: 2019-12-12
• Primary completion: 2021-07-02
• Completion: 2021-07-02
• First posted: 2019-08-05
• Last updated: 2024-07-18
• Results posted: 2024-07-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study