- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07823205
A Study to Evaluate Different Oral Formulations of KT-621
11. september 2026 opdateret af: Kymera Therapeutics, Inc.
A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of Different Oral Formulations of KT-621 in Healthy Adult Participants
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
54
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kymera Medical Director
- Telefonnummer: 857-285-5300
- E-mail: clinicaltrials@kymeratx.com
Studiesteder
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68502
- Rekruttering
- Celerion
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part A: KT-621 Test Formulation #1
Participants will receive KT-621 in different oral formulations in a one-way crossover design.
|
KT-621 Reference Oral Formulation
KT-621 Test Oral Formulation #1
KT-621 Test Oral Formulation #2
|
|
Eksperimentel: Part B: KT-621 Test Formulation #2
Participants will receive KT-621 in different oral formulations in a one-way crossover design.
|
KT-621 Reference Oral Formulation
KT-621 Test Oral Formulation #1
KT-621 Test Oral Formulation #2
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum Plasma Concentration (Cmax) of KT-621
Tidsramme: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621
Tidsramme: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621
Tidsramme: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of adverse events
Tidsramme: From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)
|
From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)
|
|
Incidence of serious adverse events
Tidsramme: From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)
|
From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. april 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
11. september 2026
Først indsendt, der opfyldte QC-kriterier
11. september 2026
Først opslået (Faktiske)
16. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KT621-HV-105
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .