NCT07187375

Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

A Phase 2, Open-Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Crinecerfont in Pediatric Subjects 0 to <2 Years of Age With Congenital Adrenal Hyperplasia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 0 Years – 23 Months
• Healthy volunteers: Not accepted

Summary

The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to \<2 years of age with congenital adrenal hyperplasia (CAH).

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Crinecerfont	Oral solution

Timeline

• Start date: 2025-09-30
• Primary completion: 2029-09-06
• Completion: 2029-10-04
• First posted: 2025-09-23
• Last updated: 2026-03-20

Locations

3 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study