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
Sex
ALL
Min age
0 Years
Max age
23 Months
Healthy volunteers
No
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Primary outcome measure(s)
Plasma Concentration of Crinecerfont — Days 7 and 15
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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