Healthy VolunteersPhase 1NCT07221084
A Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants
A Phase 1 study testing Atumelnant in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral doses in healthy Japanese and Caucasian adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Atumelnant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 27 Feb 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants, 18 to 55 years old, inclusive, at the Screening Visit.
- Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, clinical chemistry, coagulation, serology, and urinalysis. The tests may be repeated once at Screening and at admission on Day -1 if necessary and deemed appropriate by the Investigator or designee.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the Screening Visit and at admission on Day -1.
- Meeting the criteria at the time of consent for one of the following ethnic groups:
- Japanese participants must have been born in Japan to parents and grandparents of Japanese ethnic descent as evidenced by verbal confirmation and documented in a self-reported family tree form, have lived less than 10 years outside of Japan, and have no significant change in lifestyle, including diet, since leaving Japan.
- Caucasian participants must be considered White of European descent.
- Participant has a peak 30- or 60-minute ACTH stimulated serum cortisol ≥18 μg/dL during 250 μg high-dose ACTH/cosyntropin stimulation test conducted at Screening.
- Participant has normal morning serum cortisol collected at approximately 08:00 AM (±2 hours) at admission on Day -1 and does not have signs and symptoms of adrenal insufficiency as deemed by the Investigator or designee.
Who cannot join
- Participant is breastfeeding or has a positive serum pregnancy test at Screening or at admission on Day -1.
- Participant has a blood loss ≥500 mL or donated blood within 3 months prior to admission on Day -1.
- Participant has received atumelnant previously or has previously been enrolled in this clinical study.
- Participant has received any investigational drug within the past 30 days or 5 half lives, whichever is longer, prior to the first dose of study intervention on Day 1.
- Participant is unwilling to refrain from strenuous, unaccustomed exercise and sports, defined as greater than 30 minutes per day, 3 days prior to admission on Day -1.
- Participant has history of hypersensitivity to study intervention or any of the excipients or to medicinal products with similar chemical structures.
- Participant has used any prescription medication without approval of the Investigator or designee within 14 days prior to admission on Day -1. By exception, hormonal contraceptives are permitted throughout the study and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are allowed up to 14 days prior to admission on Day -1.
- Venous access considered inadequate for sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants
The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral doses in healthy Japanese and Caucasian adult participants.
Read the detailed description
This is a Phase 1, stratified randomized, double-blind, placebo-controlled, 2-cohort, 2-period, fixed-sequence study to assess the PK profile, safety, and tolerability of atumelnant after single and multiple QD oral doses in healthy Japanese and Caucasian adult participants.
Approximately 20 healthy male and female participants of either Japanese or Caucasian ethnicities will be enrolled in the study to receive the study intervention.
- Conditions
- Healthy Volunteers
- Being tested
- Atumelnant, Placebo
- 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, once daily by mouth
PlaceboDrug
Placebo, tablets, once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Cohort 1) | Experimental | Fixed-sequence cohort for Japanese participants. Receives: Drug: Atumelnant |
| Placebo (Cohort 1) | Active comparator | Fixed-sequence cohort for Japanese participants. Receives: Drug: Placebo |
| Treatment (Cohort 2) | Experimental | Fixed-sequence cohort for Caucasian participants. Receives: Drug: Atumelnant |
| Placebo (Cohort 2) | Active comparator | Fixed-sequence cohort for Caucasian participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of atumelnant
Measured: [Time Frame: Up to Day 30]
Pharmacokinetics (Tmax)
Assessment of time to maximal atumelnant concentration (Tmax)
Measured: [Time Frame: Up to Day 30]
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of Atumelnant
Measured: [Time Frame: Up to Day 30]
Secondary outcomes (6)
Number of participants with Treatment Emergent Adverse Events including Adverse Events of Special Interest (adrenal insufficiency)
Measured: [Time Frame: Up to Day 50]
Number of participants with clinically significant clinical laboratory abnormalities
Measured: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in vital signs
Measured: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in physical exam observations
Measured: [Time Frame: Up to Day 30]
Number of participants with clinically significant Electrocardiogram (ECG) abnormalities
Measured: [Time Frame: Up to Day 20]
12-lead triplicate Electrocardiogram (ECG) corrected QT interval (QTc) interval
Measured: [Time Frame: Up to Day 20]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start28 Oct 2025
- Primary completion7 Feb 2026
- Study completion27 Feb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- NCT07221084
- Sponsor's protocol ID
- CRN04894-153
- Status last verified
- Oct 2025
- First submitted
- 22 Oct 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants
- ClinicalTrials.gov ID
- NCT07221084
- Acronym / sponsor ID
- CRN04894-153
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, CRN04894, Atumelnant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 27 Oct 2025 (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.
The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral doses in healthy Japanese and Caucasian adult participants.
Detailed description
This is a Phase 1, stratified randomized, double-blind, placebo-controlled, 2-cohort, 2-period, fixed-sequence study to assess the PK profile, safety, and tolerability of atumelnant after single and multiple QD oral doses in healthy Japanese and Caucasian adult participants.
Approximately 20 healthy male and female participants of either Japanese or Caucasian ethnicities will be enrolled in the study to receive the study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment (Cohort 1) | Experimental | Drug: AtumelnantFixed-sequence cohort for Japanese participants. |
| Placebo (Cohort 1) | Active comparator | Drug: PlaceboFixed-sequence cohort for Japanese participants. |
| Treatment (Cohort 2) | Experimental | Drug: AtumelnantFixed-sequence cohort for Caucasian participants. |
| Placebo (Cohort 2) | Active comparator | Drug: PlaceboFixed-sequence cohort for Caucasian participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female participants, 18 to 55 years old, inclusive, at the Screening Visit.
- Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, clinical chemistry, coagulation, serology, and urinalysis. The tests may be repeated once at Screening and at admission on Day -1 if necessary and deemed appropriate by the Investigator or designee.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the Screening Visit and at admission on Day -1.
- Meeting the criteria at the time of consent for one of the following ethnic groups:
- Japanese participants must have been born in Japan to parents and grandparents of Japanese ethnic descent as evidenced by verbal confirmation and documented in a self-reported family tree form, have lived less than 10 years outside of Japan, and have no significant change in lifestyle, including diet, since leaving Japan.
Key exclusion criteria (8 listed)
- Participant is breastfeeding or has a positive serum pregnancy test at Screening or at admission on Day -1.
- Participant has a blood loss ≥500 mL or donated blood within 3 months prior to admission on Day -1.
- Participant has received atumelnant previously or has previously been enrolled in this clinical study.
- Participant has received any investigational drug within the past 30 days or 5 half lives, whichever is longer, prior to the first dose of study intervention on Day 1.
- Participant is unwilling to refrain from strenuous, unaccustomed exercise and sports, defined as greater than 30 minutes per day, 3 days prior to admission on Day -1.
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, once daily by mouth | Drug | Treatment (Cohort 1), Treatment (Cohort 2) |
| PlaceboPlacebo, tablets, once daily by mouth | Drug | Placebo (Cohort 1), Placebo (Cohort 2) |
Primary outcome
Pharmacokinetics (Cmax)
Time frame: [Time Frame: Up to Day 30]
Assessment of the maximum observed plasma concentration of atumelnant
Pharmacokinetics (Tmax)
Time frame: [Time Frame: Up to Day 30]
Assessment of time to maximal atumelnant concentration (Tmax)
Pharmacokinetics (AUC)
Time frame: [Time Frame: Up to Day 30]
Assessment of the plasma area under the curve of Atumelnant
6 secondary outcomes
Number of participants with Treatment Emergent Adverse Events including Adverse Events of Special Interest (adrenal insufficiency)
Time frame: [Time Frame: Up to Day 50]
Number of participants with clinically significant clinical laboratory abnormalities
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in vital signs
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in physical exam observations
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant Electrocardiogram (ECG) abnormalities
Time frame: [Time Frame: Up to Day 20]
12-lead triplicate Electrocardiogram (ECG) corrected QT interval (QTc) interval
Time frame: [Time Frame: Up to Day 20]
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 11 Mar 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 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 8 inclusion and 8 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 11 Mar 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?
Pharmacokinetics (Cmax) (time frame: [Time Frame: Up to Day 30]). The study lists 3 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 11 Mar 2026.