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RecruitingPhase 2NCT07187375

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

Sponsor

Neurocrine Biosciences

Enrollment

6 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Congenital Adrenal Hyperplasia

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).

Eligibility

Min Age: 0 YearsMax Age: 23 Months

Inclusion Criteria3

  • Be a female or male between 0 to <2 years of age at screening.
  • Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD).
  • Be on a clinically stable regimen of hydrocortisone (and fludrocortisone, if applicable) treatment.

Exclusion Criteria3

  • Have a known or suspected diagnosis of any of the other forms of classic CAH.
  • Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.
  • Have any other clinically significant medical condition or chronic disease.

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Interventions

DRUGCrinecerfont

Oral solution

Locations(3)

Neurocrine Clinical Site

Berlin, Germany

Neurocrine Clinical Site

Düsseldorf, Germany

Neurocrine Clinical Site

Heidelberg, Germany

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NCT07187375

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