A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrinetics Pharmaceuticals Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- atumelnant
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov