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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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, cabergoline or metyrapone) may participate after a 14-day washout period, if they meet other study inclusion criteria

Locations
United States
Maryland
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
RECRUITING
Bethesda
Contact Information
Primary
Crinetics Clinical Trials
clinicaltrials@crinetics.com
833-827-9741
Time Frame
Start Date: 2023-10-12
Estimated Completion Date: 2026-10
Participants
Target number of participants: 18
Treatments
Experimental: Multiple Ascending Doses
Sequential, open-label, 10-day fixed-dose cohorts.
Sponsors
Leads: Crinetics Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov