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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804669
Other study ID # CRN04894-04
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 12, 2023
Est. completion date October 2026

Study information

Verified date January 2024
Source Crinetics Pharmaceuticals Inc.
Contact Crinetics Clinical Trials
Phone 833-827-9741
Email clinicaltrials@crinetics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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])


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Male or female, aged 18-75 years 2. Evidence of 'active' ACTH-dependent Cushing's syndrome within 14 days of Day 1 3. 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. A UFC more than 8-fold ULN 6. Use of mitotane 7. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

Study Design


Intervention

Drug:
CRN04894
CRN04894 is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

Locations

Country Name City State
United States National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
Crinetics Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with treatment emergent adverse events (TEAEs) Up to Day 15
Primary Proportion of participants with adrenal insufficiency Up to Day 15
Primary Proportion of participants with safety findings determined by laboratory testing Up to Day 15
Primary Assessment of the maximum observed plasma concentration of CRN04894 Up to Day 15
Primary Assessment of the time to achieve maximum observed plasma concentration of CRN04894 Up to Day 15
Primary Assessment of the plasma area under the curve of CRN04894 Up to Day 15
Secondary Change from baseline in early morning serum cortisol Day 11
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