Clinical trial

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)

Name

CRN04894-04

Description

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 \[EAS\])

Trial arms

Trial start

2023-10-12

Estimated PCD

2026-10-01

Trial end

2026-10-01

Status

Recruiting

Phase

Early phase I

Treatment

CRN04894

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

Arms:

Multiple Ascending Doses

Size

Primary endpoint

Proportion of participants with treatment emergent adverse events (TEAEs)

Up to Day 15

Proportion of participants with adrenal insufficiency

Up to Day 15

Proportion of participants with safety findings determined by laboratory testing

Up to Day 15

Assessment of the maximum observed plasma concentration of CRN04894

Up to Day 15

Assessment of the time to achieve maximum observed plasma concentration of CRN04894

Up to Day 15

Assessment of the plasma area under the curve of CRN04894

Up to Day 15

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-01-24

1 organization

1 product

3 indications

Product

CRN04894

Indication

Cushing's syndrome

Indication

Cushing disease

Indication

Ectopic ACTH Syndrome

Organization

Crinetics Pharmaceuticals