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NCT Number: NCT07823205

A Study to Evaluate Different Oral Formulations of KT-621

This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KT-621

Drug

KT-621 Reference Oral Formulation

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of KT-621

    Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621

    Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)

  3. Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621

    Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)

Secondary outcomes

  1. Incidence of adverse events

    Time frame: From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)

  2. Incidence of serious adverse events

    Time frame: From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)

Study contacts

Contact information is provided by the study sponsor or research team.

Kymera Medical Director

CONTACT

[email protected]

857-285-5300

Sponsors and collaborators

Lead sponsor

Kymera Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of Different Oral Formulations of KT-621 in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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