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 \[EAS\])
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 atumelnant (also known as CRN04894) (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States
RECRUITINGProportion of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to Day 15
Proportion of participants with adrenal insufficiency
Time frame: Up to Day 15
Proportion of participants with safety findings determined by laboratory testing
Time frame: Up to Day 15
Assessment of the maximum observed plasma concentration of CRN04894
Time frame: Up to Day 15
Assessment of the time to achieve maximum observed plasma concentration of CRN04894
Time frame: Up to Day 15
Assessment of the plasma area under the curve of CRN04894
Time frame: Up to Day 15
Change from baseline in early morning serum cortisol
Time frame: Up to Day 15
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