Healthy VolunteersPhase 1NCT07570082
Drug-Drug Interaction Study of Atumelnant in Healthy Participants
A Phase 1 study testing Atumelnant, Carbamazepine and Midazolam in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Atumelnant, Carbamazepine and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 30 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, CRN04894, Atumelnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtumelnantDrug
Also called CRN04894
Atumelnant, tablets
CarbamazepineDrug
CYP3A4 inducer
MidazolamDrug
CYP3A4 substrate
DigoxinDrug
P-gp substrate
MetforminDrug
MATE1/2-K substrate
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | atumelnant, carbamazepine (CYP3A4 Inducer) Receives: Drug: Atumelnant; Drug: Carbamazepine |
| Cohort 2 | Experimental | atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate) Receives: Drug: Atumelnant; Drug: Midazolam; Drug: Digoxin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Pharmacokinetics (AUC 0-last)
Measured: Up to Day 34
Cohort 1: Pharmacokinetics (AUC 0-inf)
Measured: Up to Day 34
Cohort 1: Pharmacokinetics (Cmax)
Measured: Up to Day 34
Cohort 2: Pharmacokinetics (AUC 0-last)
Measured: Up to Day 21
Cohort 2: Pharmacokinetics (AUC 0-inf)
Measured: Up to Day 21
Cohort 2: Pharmacokinetics (Cmax)
Measured: Up to Day 21
Secondary outcomes (2)
Cohort 1: Number of participants with Treatment Emergent Adverse Events
Measured: Up to Day 34
Cohort 2: Number of participants with Treatment Emergent Adverse Events
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start28 May 2026
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570082
- Sponsor's protocol ID
- CRN04894-131
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07570082
- Acronym / sponsor ID
- CRN04894-131
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, CRN04894, Atumelnant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Atumelnant, Drug: Carbamazepineatumelnant, carbamazepine (CYP3A4 Inducer) |
| Cohort 2 | Experimental | Drug: Atumelnant, Drug: Midazolam, Drug: Digoxin, Drug: Metforminatumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtumelnantAlso: CRN04894Atumelnant, tablets | Drug | Cohort 1, Cohort 2 |
| CarbamazepineCYP3A4 inducer | Drug | Cohort 1 |
| MidazolamCYP3A4 substrate | Drug | Cohort 2 |
| DigoxinP-gp substrate | Drug | Cohort 2 |
| MetforminMATE1/2-K substrate | Drug | Cohort 2 |
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atumelnant, Carbamazepine and Midazolam in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Pharmacokinetics (AUC 0-last) (time frame: Up to Day 34). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.