Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

Part of paid clinical trials in San Francisco, California.

Sponsor
Neurocrine Switzerland GmbH
Study ID
NCT07536269
Phase
PHASE2
Status
Recruiting
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Conditions

  • Congenital Adrenal Hyperplasia

Eligibility Criteria

Sex
ALL
Age
3 Months - 47 Months
Healthy Volunteers
Not accepted

Interventions

  • Crinecerfont — DRUG
    Oral solution

Study Details

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

Key Dates

First listed
Apr 17, 2026
Start date
Jul 1, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Crinecerfont
    Participants with CAH will receive crinecerfont.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: Day 1 up to 28 weeks ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteSan FranciscoCalifornia94143-
Neurocrine Clinical SiteHartfordConnecticut06106-
Neurocrine Clinical SiteAtlantaGeorgia30329-
Neurocrine Clinical SiteChicagoIllinois60618-
Neurocrine Clinical SiteIndianapolisIndiana46202-
Neurocrine Clinical SiteAnn ArborMichigan48109-
Neurocrine Clinical SiteMinneapolisMinnesota55454-
Neurocrine Clinical SitePhiladelphiaPennsylvania19104-
Neurocrine Clinical SiteDallasTexas75235-
Neurocrine Clinical SiteSeattleWashington98101-

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Neurocrine Clinical Site· San Francisco, CANeurocrine Clinical Site· Hartford, CTNeurocrine Clinical Site· Atlanta, GANeurocrine Clinical Site· Chicago, ILNeurocrine Clinical Site· Indianapolis, INNeurocrine Clinical Site· Ann Arbor, MI

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