Drug-Drug Interaction Study of Atumelnant in Healthy Participants

Running, not enrolling · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07570082

Run by

Crinetics Pharmaceuticals Inc.

People needed

46

Starts

2026-05-28

Expected to finish

2026-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Crinetics Study Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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