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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution

• Registration Number: NCT06048887
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-18
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (Part 1)	Placebo Oral Solution	-
Multiple Ascending Dose (Part 2)	CRN04894 Oral Solution	-
Multiple Ascending Dose (Part 2)	Placebo Oral Solution	-
Single Ascending Dose (Part 1)	CRN04894 Oral Solution	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

QPS-Miami Research Associates; 🇺🇸 Miami, Florida, United States