- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07818967
A Study of Abemaciclib (LY2835219) in Healthy Participants
11 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
15
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-post: LillyTrials@Lilly.com
Studera Kontakt Backup
- Namn: Physicians interested in becoming principal investigators please contact
- Telefonnummer: 13176154559
- E-post: clinical_inquiry_hub@lilly.com
Studieorter
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-
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Singapore, Singapore, 138623
- Lilly Centre for Clinical Pharmacology
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Abemaciclib (Test Formulation 1)
Administered orally in one of three treatment periods.
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Administered orally as a tablet in one of three treatment periods.
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Experimentell: Abemaciclib (Test Formulation 2)
Administered orally in one of three treatment periods.
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Administered orally in one of three treatment periods.
|
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Experimentell: Abemaciclib (Reference Formulation 1)
Administered orally in one of three treatment periods.
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Administered orally as a tablet in one of three treatment periods.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
Tidsram: Baseline through Day 45
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Baseline through Day 45
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]
Tidsram: Baseline through Day 45
|
Baseline through Day 45
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 november 2026
Avslutad studie (Beräknad)
1 november 2026
Studieregistreringsdatum
Först inskickad
26 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
11 september 2026
Första postat (Faktisk)
14 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 27817
- I3Y-MC-JPEJ (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .