NCT06048887
Completed
Phase 1
A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CRN04894 Oral Solution
- Conditions
- Healthy Volunteers
- Sponsor
- Crinetics Pharmaceuticals Inc.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with treatment-emergent adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Single Ascending Dose (Part 1)
Intervention: CRN04894 Oral Solution
Single Ascending Dose (Part 1)
Intervention: Placebo Oral Solution
Multiple Ascending Dose (Part 2)
Intervention: CRN04894 Oral Solution
Multiple Ascending Dose (Part 2)
Intervention: Placebo Oral Solution
Outcomes
Primary Outcomes
Percentage of subjects with treatment-emergent adverse events
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Proportion of participants with a clinically significant safety laboratory observation
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary Outcomes
- Pharmacokinetics (Cmax)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (Tmax)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (AUC)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (T1/2)(Part 1 - up to Day 8; Part 2 - up to Day 20)
Study Sites (1)
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