A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)
Crinetics Pharmaceuticals Inc.
18 participants
Oct 12, 2023
INTERVENTIONAL
Conditions
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 \[EAS\])
Eligibility
Inclusion Criteria3
- Adult male or female, aged 18 years or more
- Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
- Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
Exclusion Criteria6
- Women who are pregnant or lactating
- History of bilateral adrenalectomy
- Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
- Presence of any known malignancy
- Use of mitotane
- Previous unsuccessful surgery for Cushing's syndrome within 6 weeks
Interventions
Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05804669