Drug-Drug Interaction Study of Atumelnant in Healthy Participants

NCT07570082 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CRN04894-131
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; CRN04894; Atumelnant

Outcome Measures

Primary Outcomes (6)

• Cohort 1: Pharmacokinetics (AUC 0-last)

  Up to Day 34

• Cohort 1: Pharmacokinetics (AUC 0-inf)

  Up to Day 34

• Cohort 1: Pharmacokinetics (Cmax)

  Up to Day 34

• Cohort 2: Pharmacokinetics (AUC 0-last)

  Up to Day 21

• Cohort 2: Pharmacokinetics (AUC 0-inf)

  Up to Day 21

• Cohort 2: Pharmacokinetics (Cmax)

  Up to Day 21

Secondary Outcomes (2)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

atumelnant, carbamazepine (CYP3A4 Inducer)

Drug: Atumelnant; Drug: Carbamazepine

Cohort 2

EXPERIMENTAL

atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)

Drug: Atumelnant; Drug: Midazolam; Drug: Digoxin; Drug: Metformin

Interventions

Atumelnant DRUG

Atumelnant, tablets

Also known as: CRN04894

Cohort 1; Cohort 2

Carbamazepine DRUG

CYP3A4 inducer

Cohort 1

Midazolam DRUG

CYP3A4 substrate

Cohort 2

Digoxin DRUG

P-gp substrate

Cohort 2

Metformin DRUG

MATE1/2-K substrate

Cohort 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

Crinetics Study Site

Lincoln, Nebraska, 68502, United States

RECRUITING

MeSH Terms

Interventions

Carbamazepine; Midazolam; Digoxin; Metformin

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Crinetics Clinical Trials

CONTACT

833-827-9741; clinicaltrials@crinetics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)