RecruitingPhase 1

Drug-Drug Interaction Study of Atumelnant in Healthy Participants

United States46 participantsStarted 2026-05-06

Plain-language 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.

Who can participate

Age range19 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.
✓. BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit.
✓. 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.
✓. 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

✕. 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.
✕. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
✕. Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
✕. Female participant of childbearing potential.
✕. Had prior treatment with atumelnant.
✕. 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.
✕. History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
✕. Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.

What they're measuring

Cohort 1: Pharmacokinetics (AUC 0-last)

Timeframe: Up to Day 34

Cohort 1: Pharmacokinetics (AUC 0-inf)

Timeframe: Up to Day 34

Cohort 1: Pharmacokinetics (Cmax)

Timeframe: Up to Day 34

Cohort 2: Pharmacokinetics (AUC 0-last)

Timeframe: Up to Day 21

Cohort 2: Pharmacokinetics (AUC 0-inf)

Timeframe: Up to Day 21

Cohort 2: Pharmacokinetics (Cmax)

Timeframe: Up to Day 21

Trial details

NCT IDNCT07570082

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Crinetics Clinical Trials

833-827-9741 clinicaltrials@crinetics.com

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range19 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.
✓. BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit.
✓. 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.
✓. 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

✕. 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.
✕. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
✕. Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
✕. Female participant of childbearing potential.
✕. Had prior treatment with atumelnant.
✕. 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.
✕. History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
✕. Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.

What they're measuring

Cohort 1: Pharmacokinetics (AUC 0-last)

Timeframe: Up to Day 34

Cohort 1: Pharmacokinetics (AUC 0-inf)

Timeframe: Up to Day 34

Cohort 1: Pharmacokinetics (Cmax)

Timeframe: Up to Day 34

Cohort 2: Pharmacokinetics (AUC 0-last)

Timeframe: Up to Day 21

Cohort 2: Pharmacokinetics (AUC 0-inf)

Timeframe: Up to Day 21

Cohort 2: Pharmacokinetics (Cmax)

Timeframe: Up to Day 21