Healthy Volunteers
Conditions
Keywords
Healthy volunteers, CRN04894, Atumelnant
Brief summary
This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1/2-K substrates in healthy participants.
Detailed description
This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants. Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.
Interventions
DRUGAtumelnant
Atumelnant, tablets
DRUGCarbamazepine
CYP3A4 inducer
DRUGMidazolam
CYP3A4 substrate
DRUGDigoxin
P-gp substrate
DRUGMetformin
MATE1/2-K substrate
Sponsors
Crinetics Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit. 2. BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit. 3. Is willing and able to comply with all study procedures and restrictions, including fasting and consumption of protocol-specified standardized meal for required study measurements; inpatient admission; follow-up contact; receipt of rescue therapy, if necessary; abstinence from tobacco, alcohol, drugs, and from strenuous unaccustomed exercise and sports (defined as greater than 30 minutes per day) during the study period. 4. Normal adrenocorticotropic hormone (ACTH)-stimulated cortisol test at the screening visit and does not have signs and symptoms of adrenal insufficiency as deemed by the PI or designee.
Exclusion criteria
1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating. 4. Female participant of childbearing potential. 5. Had prior treatment with atumelnant. 6. Participation in another clinical study within 30 days or received any investigational drug within 5 half-lives prior to the first dosing, whichever is longer. The time window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study. 7. History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds. 8. Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing. 9. Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, vitamin supplements, or other food supplements within 14 days or 5 half-lives prior to the first dosing, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 2: Pharmacokinetics (AUC 0-last) | Up to Day 21 |
| Cohort 2: Pharmacokinetics (Cmax) | Up to Day 21 |
| Cohort 1: Pharmacokinetics (Cmax) | Up to Day 34 |
| Cohort 2: Pharmacokinetics (AUC 0-inf) | Up to Day 21 |
| Cohort 1: Pharmacokinetics (AUC 0-last) | Up to Day 34 |
| Cohort 1: Pharmacokinetics (AUC 0-inf) | Up to Day 34 |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Number of participants with Treatment Emergent Adverse Events | Up to Day 34 |
| Cohort 2: Number of participants with Treatment Emergent Adverse Events | Up to Day 21 |
Countries
United States
Outcome results
None listed