NCT05804669PHASE1, PHASE2Recruiting

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

Crinetics Pharmaceuticals Inc.

Start Date

10/12/2023

Completion Date

10/1/2026

Summary

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

Detailed Description

This is a Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with atumelnant (also known as CRN04894) (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Adult male or female, aged 18 years or more 2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome 3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1 4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria Exclusion Criteria: 1. Women who are pregnant or lactating 2. History of bilateral adrenalectomy 3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm 4. Presence of any known malignancy 5. Use of mitotane 6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

Interventions

DRUG

atumelnant

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Conditions

Cushing SyndromeCushing DiseaseEctopic ACTH Syndrome

Locations

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland 20892

United States