Atumelnant interactions with other medicines in healthy adults

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

This trial will test whether a strong CYP3A4 inducer and several common probe drugs change how healthy adults absorb and clear atumelnant.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Crinetics Pharmaceuticals Inc. (industry)
• Locations: 1 site (Lincoln, Nebraska)
• Trial ID: NCT07570082 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, two-cohort trial enrolls healthy adults to characterize pharmacokinetic interactions between atumelnant and other drugs. Cohort 1 (about 20 participants) examines the effect of a strong CYP3A4 inducer on atumelnant, while Cohort 2 (about 26 participants) evaluates atumelnant's effects on probe substrates for CYP3A4 (midazolam), P-gp (digoxin), and MATE1/2-K (metformin). Participants will undergo inpatient stays, fasting and standardized meals, and serial blood and urine sampling to measure drug concentrations. Key eligibility includes ages 19–55, BMI 18–32, and females must be non-childbearing potential.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 19–55 with BMI 18–32 who are non-childbearing potential (if female) and able to comply with inpatient visits and study procedures.

Not a fit: People with active medical conditions, pregnant or breastfeeding individuals, children, or those taking chronic medications are unlikely to benefit from participating.

Why it matters

Potential benefit: If positive, the results could guide safer co-prescribing and dosing of atumelnant with other medicines.

How similar studies have performed: Drug–drug interaction studies using carbamazepine, midazolam, digoxin, and metformin are standard and have successfully defined enzyme and transporter effects for other drugs, though atumelnant-specific data are limited.

Eligibility criteria

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.

Where this trial is running

Lincoln, Nebraska

• Crinetics Study Site — Lincoln, Nebraska, United States (RECRUITING)

Study contacts

• Study coordinator: Crinetics Clinical Trials

Conditions: Healthy Volunteers, Healthy volunteers, CRN04894, Atumelnant