---
title: Drug-Drug Interaction Study of Atumelnant in Healthy Participants
nct_id: NCT07570082
overall_status: RECRUITING
phase: PHASE1
sponsor: Crinetics Pharmaceuticals Inc.
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07570082.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07570082"
ct_last_update_post_date: 2026-05-06
last_seen_at: "2026-05-12T06:56:15.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Drug-Drug Interaction Study of Atumelnant in Healthy Participants

**Official Title:** 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

**NCT ID:** [NCT07570082](https://clinicaltrials.gov/study/NCT07570082)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 46
- **Lead Sponsor:** Crinetics Pharmaceuticals Inc.
- **Conditions:** Healthy Volunteers
- **Start Date:** 2026-05-06
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-05-06

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Cohort 1** (EXPERIMENTAL) — atumelnant, carbamazepine (CYP3A4 Inducer)
- **Cohort 2** (EXPERIMENTAL) — atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)

## Interventions

- **Atumelnant** (DRUG) — Atumelnant, tablets
- **Carbamazepine** (DRUG) — CYP3A4 inducer
- **Midazolam** (DRUG) — CYP3A4 substrate
- **Digoxin** (DRUG) — P-gp substrate
- **Metformin** (DRUG) — MATE1/2-K substrate

## Primary Outcomes

- **Cohort 1: Pharmacokinetics (AUC 0-last)** _(time frame: Up to Day 34)_
- **Cohort 1: Pharmacokinetics (AUC 0-inf)** _(time frame: Up to Day 34)_
- **Cohort 1: Pharmacokinetics (Cmax)** _(time frame: Up to Day 34)_
- **Cohort 2: Pharmacokinetics (AUC 0-last)** _(time frame: Up to Day 21)_
- **Cohort 2: Pharmacokinetics (AUC 0-inf)** _(time frame: Up to Day 21)_
- **Cohort 2: Pharmacokinetics (Cmax)** _(time frame: Up to Day 21)_

## Secondary Outcomes

- **Cohort 1: Number of participants with Treatment Emergent Adverse Events** _(time frame: Up to Day 34)_
- **Cohort 2: Number of participants with Treatment Emergent Adverse Events** _(time frame: Up to Day 21)_

## Locations (1)

- Crinetics Study Site, Lincoln, Nebraska, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.crinetics study site|lincoln|nebraska|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07570082.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07570082*  
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