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Healthy volunteers help test new Drug's safety

NCT ID NCT07221084

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called atumelnant in 21 healthy adults from Japanese and Caucasian backgrounds. The goal was to see how the drug moves through the body and if it is safe. Participants took the drug or a placebo by mouth once daily. This early-stage study does not aim to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Oct 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Crinetics Study Site

    Glendale, California, 91206, United States

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