A study to evaluate the safety and PK of CRN04894 for the treatment of Cushing's Syndrome
A study to evaluate the safety and PK of CRN04894 for the treatment of Cushing's Syndrome
ClinicalTrials.gov ID: NCT05804669
Sponsor: Crinetics Pharmaceuticals Inc.
Information provided by: Crinetics Pharmaceuticals Inc. (Responsible Party)
Last Update Posted: 2024-07-26
Brief 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])
Detailed 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.
Official Title:
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)
Intervention / Treatment:
- Drug: CRN04894
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-10-12
|
| Primary Completion (Estimated) |
2026-10-01
|
| Study Completion (Estimated) |
2026-10-01
|
| Enrollment (Estimated) | 18 |
| Study Type | Interventional |
| Phase | Phase 1 Phase 2 |
| Other Study ID Numbers |
CRN04894-04
|