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A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

Primary Purpose

Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CRN04894

About this trial

This is an interventional treatment trial for Cushing Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, aged 18-75 years Vaccination against COVID-19 according to current CDC recommendations Evidence of 'active' ACTH-dependent Cushing's syndrome within 14 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 Exclusion Criteria: Women who are pregnant or lactating History of bilateral adrenalectomy Previous pituitary MRI findings of a lesion within 3 mm of the optic chiasm Presence of any known malignancy A UFC more than 5-fold ULN Use of mitotane Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

Sites / Locations

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple Ascending Doses

Arm Description

Sequential, open-label, 10-day fixed-dose cohorts.

Outcomes

Primary Outcome Measures

Proportion of participants with treatment emergent adverse events (TEAEs)

Proportion of participants with adrenal insufficiency

Proportion of participants with safety findings determined by laboratory testing

Assessment of the maximum observed plasma concentration of CRN04894

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

Assessment of the plasma area under the curve of CRN04894

Secondary Outcome Measures

Change from baseline in early morning serum cortisol

Full Information

NCT ID

NCT05804669

First Posted

March 27, 2023

Last Updated

March 27, 2023

Sponsor

Crinetics Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05804669

Brief Title

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2023 (Anticipated)

Primary Completion Date

April 2026 (Anticipated)

Study Completion Date

April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crinetics Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multiple Ascending Doses

Arm Type

Experimental

Arm Description

Sequential, open-label, 10-day fixed-dose cohorts.

Intervention Type

Drug

Intervention Name(s)

CRN04894

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants with treatment emergent adverse events (TEAEs)

Time Frame

Up to Day 15

Title

Proportion of participants with adrenal insufficiency

Time Frame

Up to Day 15

Title

Proportion of participants with safety findings determined by laboratory testing

Time Frame

Up to Day 15

Title

Assessment of the maximum observed plasma concentration of CRN04894

Time Frame

Up to Day 15

Title

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

Time Frame

Up to Day 15

Title

Assessment of the plasma area under the curve of CRN04894

Time Frame

Up to Day 15

Secondary Outcome Measure Information:

Title

Change from baseline in early morning serum cortisol

Time Frame

Day 11

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Crinetics Clinical Trials

Phone

833-827-9741

clinicaltrials@crinetics.com

Facility Information:

Facility Name

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lynnette K Nieman, MD

Phone

301-496-8935

niemanl@nih.gov

First Name & Middle Initial & Last Name & Degree

Lynnette K Nieman, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

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