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A Study of Abemaciclib (LY2835219) in Healthy Participants

11. september 2026 opdateret af: Eli Lilly and Company

A Phase 1, Open-Label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Abemaciclib (LY2835219) Test and Reference Formulations and an Alternate Administration Method, in Healthy Participants.

The main purpose of this study is to compare different forms of abemaciclib (LY2835219) to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects. For each participant, the study will last about 12 weeks and will include 3 stays in the Clinical Research Unit (CRU). Each stay will last 10 days.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Telefonnummer: 1-317-615-4559
  • E-mail: LillyTrials@Lilly.com

Undersøgelse Kontakt Backup

Studiesteder

      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

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
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Have a body mass index (BMI) within the range of 18 to 32 kilograms per square meter (kg/m²), inclusive, and have a body weight of 45 kilograms (kg) or greater.
  • Individuals assigned male at birth (AMAB) should be sterile, including vasectomy.
  • Individuals who are assigned female at birth (AFAB) and are individuals not of childbearing potential (INOCBP).
  • Have clinical laboratory test results within normal reference range for the population or investigative site.
  • Have a hemoglobin level of 12.5 grams per deciliter (g/dL) or greater for males, or 11.4 g/dL for females.
  • Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

  • Have known allergies to abemaciclib, related compounds, or any components of the formulations, or have a history of significant atopy.
  • Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
  • Have abnormal blood pressure as determined by the investigator.
  • Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes.
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that could significantly alter the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of study data.
  • Have known or ongoing psychiatric disorders.
  • Have used or intend to use over the counter or prescription medication, or herbal supplements, within 14 days prior to the first dose. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable.
  • Use or intend to use any medications or products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 14 days prior to Study Day 1, unless deemed acceptable by the investigator or designee.
  • Use or intend to use medications that are moderate or strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), including cannabidiol- or cannabis-containing products, within 14 days prior to Study Day 1 until completion of the follow-up phone call.
  • Regularly use known drugs of abuse.
  • Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies.
  • Have a positive Hepatitis C Virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV Ribonucleic Acid (RNA) test is negative.
  • Show evidence of hepatitis B or positive hepatitis B surface antigen.
  • Have made a blood donation of 450 milliliters (mL) or greater, or have participated in a clinical study that required a blood volume of 400 mL or more since the last study visit, within the last 3 calendar months.
  • Are unwilling to refrain from strenuous exercise for at least 72 hours prior to each dose and during each inpatient stay.
  • Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator, or are unwilling to stop alcohol consumption for at least 48 hours prior to each Clinical Research Unit (CRU) admission until discharge from the CRU in each treatment period.
  • Are unwilling to refrain from consuming caffeine- or xanthine- containing products from at least 48 hours prior to each CRU admission until discharge from the CRU in each treatment period.
  • Are currently, or have been, smokers or users of tobacco or nicotine replacement products within the 6 months prior to the first CRU admission, or have a positive cotinine test at screening.
  • Are unwilling to comply with the dietary requirements and restrictions of this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Abemaciclib (Test Formulation 1)
Administered orally in one of three treatment periods.
Administered orally as a tablet in one of three treatment periods.
Eksperimentel: Abemaciclib (Test Formulation 2)
Administered orally in one of three treatment periods.
Administered orally in one of three treatment periods.
Eksperimentel: Abemaciclib (Reference Formulation 1)
Administered orally in one of three treatment periods.
Administered orally as a tablet in one of three treatment periods.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
Tidsramme: Baseline through Day 45
Baseline through Day 45

Sekundære resultatmål

Resultatmål
Tidsramme
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]
Tidsramme: Baseline through Day 45
Baseline through Day 45

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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. september 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

26. august 2026

Først indsendt, der opfyldte QC-kriterier

11. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 27817
  • I3Y-MC-JPEJ (Anden identifikator: Eli Lilly and Company)

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

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