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Trial Title:
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
NCT ID:
NCT05804669
Condition:
Cushing Syndrome
Cushing Disease
Ectopic ACTH Syndrome
Conditions: Official terms:
ACTH-Secreting Pituitary Adenoma
ACTH Syndrome, Ectopic
Pituitary ACTH Hypersecretion
Cardiac Complexes, Premature
Cushing Syndrome
Syndrome
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CRN04894
Description:
CRN04894 is an orally active investigational agent which antagonizes the action of ACTH
at its receptor administered as oral tablets.
Arm group label:
Multiple Ascending Doses
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 CRN04894 (an adrenocorticotropic hormone [ACTH]
receptor antagonist) over a 10-day treatment period in participants with ACTH-dependent
Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS]).Participants will
receive oral CRN04894 once daily for 10 days, followed by monitoring during 4 'wash-out'
days.
Criteria for eligibility:
Criteria:
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,
cabergoline or metyrapone) may participate after a 14-day washout period, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address:
City:
Bethesda
Zip:
20892
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lynnette K Nieman, MD
Phone:
301-496-8935
Email:
niemanl@nih.gov
Investigator:
Last name:
Lynnette K Nieman, MD
Email:
Principal Investigator
Start date:
October 12, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Crinetics Pharmaceuticals Inc.
Agency class:
Industry
Source:
Crinetics Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804669
