A Study of LY900014 Formulations in Healthy Participants
12. maj 2020 opdateret af: Eli Lilly and Company
Safety, Tolerability, Pharmacokinetics and Glucodynamics of Multiple Insulin Lispro (LY900014) Formulations
This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen.
The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels.
Side effects and tolerability were documented.
The study was to be conducted in two parts (Part A and Part B) to achieve its objectives.
Each part of the study was to last for about 11 to 12 weeks, including screening and follow up.
Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
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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Singapore, Singapore, 117597
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
21 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
Exclusion Criteria:
- Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the 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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Part A: LY900014 Test A
Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
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Administreret SC
Andre navne:
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Eksperimentel: Part A:Insulin Lispro
Reference formulation.
15 U insulin lispro administered SC in one of five periods.
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Administreret SC
Andre navne:
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Eksperimentel: Part A: LY900014 Test B
Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
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Administreret SC
Andre navne:
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Eksperimentel: Part A: LY900014 Test C
Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.
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Administreret SC
Andre navne:
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Eksperimentel: Part A: LY900014 Test D
Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
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Administreret SC
Andre navne:
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Eksperimentel: Part B: LY900014
Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.
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Administreret SC
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
Tidsramme: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
Tidsramme: Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
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The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain).
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Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
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Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Tidsramme: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose
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Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
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Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose
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Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability
Tidsramme: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose
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Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
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Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose
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Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability
Tidsramme: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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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. januar 2015
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
11. december 2014
Først indsendt, der opfyldte QC-kriterier
11. december 2014
Først opslået (Skøn)
16. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2020
Sidst verificeret
1. september 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15645
- I8B-FW-ITRA (Anden identifikator: Eli Lilly and Company)
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