A Study of Merestinib (LY2801653) in Healthy Participants
25. august 2016 opdateret af: Eli Lilly and Company
The Effect of Food on the Bioavailability of Merestinib in Healthy Subjects
The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state.
The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.
In addition, the tolerability of the study drug will be evaluated.
Information about any side effects that may occur will also be collected.
The study will last approximately 28 days.
Screening is required within 28 days prior to the start of the study.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Florida
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Daytona Beach, Florida, Forenede Stater, 32117
- Covance Clinical Research Inc
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-
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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Generally healthy sterile male and female participants
- Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- Are willing and able to eat the protocol specified high-fat breakfast
Exclusion Criteria:
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have donated blood of more than 500 milliliters (mL) within the last month
- Cannot stop taking over-the-counter (OTC) or prescription medications that alter gastric pH, at least 14 days prior to first dosing
- Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product
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: Merestinib Fasted
Single dose of merestinib administered in fasted state in one of three periods
|
Indgives oralt
Andre navne:
|
|
Eksperimentel: Merestinib Standard Meal
Single dose of merestinib administered with a standard meal in one of three periods
|
Indgives oralt
Andre navne:
|
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Eksperimentel: Merestinib High-Fat Meal
Single dose of merestinib administered with a high-fat meal in one of three periods
|
Indgives oralt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State
Tidsramme: Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
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
1. maj 2016
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
19. maj 2016
Først indsendt, der opfyldte QC-kriterier
19. maj 2016
Først opslået (Skøn)
20. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 16439
- I3O-MC-JSBH (Anden identifikator: Eli Lilly and Company.)
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 .
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