Healthy Volunteers
Conditions
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.
Interventions
DRUGCRN04894 Oral Solution
CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Placebo
Sponsors
Crinetics Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (Cmax) | Part 1 - up to Day 8; Part 2 - up to Day 20 | Assessment of the maximum observed plasma concentration of CRN04894 |
| Pharmacokinetics (T1/2) | Part 1 - up to Day 8; Part 2 - up to Day 20 | Assessment of elimination half-life 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 |
Other
| 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 |
Countries
United States
Outcome results
None listed