Three pill versions of one drug go head to head in the bloodstream

NCT ID NCT07823205

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are comparing three oral formulations of an experimental drug called KT-621 to see how much of each version reaches the bloodstream. The study enrolls 54 healthy adults who take the different formulations in sequence, with blood samples measuring drug levels over time. The goal is to identify which formulation the body absorbs best and to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KT-621, an experimental oral drug tested in three different formulations
What this could lead to
If one formulation delivers KT-621 into the bloodstream more reliably, it could become the version researchers carry into later trials for the condition KT-621 targets.
What could go wrong
This is an early Phase 1 study in 54 healthy adults, so it can only show how the drug is absorbed and tolerated, not whether it treats any disease. Formulations that look good here may still fail in larger studies.
Why investors are watching

Kymera Therapeutics runs this Phase 1 trial to compare how much KT-621 reaches the bloodstream from different oral formulations, and to check safety in 54 healthy adults. For a small company, the result shapes which pill form moves into later testing, so a clear answer here affects the whole development plan.

If it works: If one formulation delivers KT-621 reliably and safely, Kymera can pick it for larger trials and avoid reformulation work later. That could keep the program on schedule.

If it fails: If the formulations perform poorly or safety problems appear, Kymera may need to redesign the drug's oral form and repeat early testing. Phase 1 trials often fail, and any delay pushes later studies back.

AI-written from the trial record. Speculative, and not investment advice.

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

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

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: * Participants with a weight of at least 50 kilograms (kg) if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening. * Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and restrictions listed in the ICF and in this protocol. * Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders. * Participants who have a clinically relevant surgical history (for example, surgery of the GI tract that could interfere with the PK of the study medication). Note: prior appendectomy or cholecystectomy is not exclusionary. * Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. * Participants who have acute GI symptoms at the time of Screening or admission to the CRU (for example, nausea, vomiting, diarrhea, heartburn). * Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening or on admission to the CRU. * Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives, or time determined by local requirements (whichever is longer) prior to admission to the CRU. * Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of KT-621. * Male participants (and their partners of childbearing potential) and female participants who do not agree to the contraception requirements as specified in the clinical protocol. * Female participants who are pregnant, lactating, or breastfeeding, or plan to become pregnant during study participation or within 30 days of the last dose of KT-621. * Female participants with a positive or undetermined pregnancy result at the Screening visit or at admission to the CRU.

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As listed by the trial registrant

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

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Celerion

    RECRUITING

    Lincoln, Nebraska, 68502, United States

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