Status:
RECRUITING
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
Lead Sponsor:
Crinetics Pharmaceuticals Inc.
Conditions:
Cushing Syndrome
Cushing Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
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 associat...
Eligibility Criteria
Inclusion Criteria:
- 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
- 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:
- 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
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05804669
Start Date
October 12 2023
End Date
October 1 2026
Last Update
April 10 2025
Active Locations (1)
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1
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States, 20892