Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo Oral Solution; Drug: CRN04894 Oral Solution

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • QPS-Miami Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
• Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
• ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion Criteria:

• Use of topical, nasal, inhaled, or oral corticosteroids.
• Use of any investigational drug within the past 60 days.
• Have a medically significant illness within 30 days prior to screening.
• Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
• Unstable psychological disorder ≤1 year prior to Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose (Part 1)	Drug: Placebo Oral Solution; Placebo; Drug: CRN04894 Oral Solution; CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Experimental: Multiple Ascending Dose (Part 2)	Drug: Placebo Oral Solution; Placebo; Drug: CRN04894 Oral Solution; CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with treatment-emergent adverse events	Part 1 - up to Day 8; Part 2 - up to Day 20
Proportion of participants with a clinically significant safety laboratory observation	Part 1 - up to Day 8; Part 2 - up to Day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (AUC)	Assessment of the plasma area under the curve of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Cmax)	Assessment of the maximum observed plasma concentration of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Tmax)	Assessment of time to maximal CRN04894 concentration (Tmax)	Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (T1/2)	Assessment of elimination half-life of CRN04894	Part 1 - up to Day 8; Part 2 - up to Day 20

Other Outcome Measures

Outcome Measure	Time Frame
Change in ACTH-stimulated serum cortisol	Part 1 - Day 1; Part 2 - Day 10
Change in serum cortisol	Part 1 - up to Day 8; Part 2 - up to Day 20

Collaborators and Investigators

• Sponsor: Crinetics Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CRN04894-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No