A Study of LY900014 Formulations in Healthy Participants
12. mai 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
29
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
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.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Part A: LY900014 Test A
Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
Administrert SC
Andre navn:
|
|
Eksperimentell: Part A:Insulin Lispro
Reference formulation.
15 U insulin lispro administered SC in one of five periods.
|
Administrert SC
Andre navn:
|
|
Eksperimentell: Part A: LY900014 Test B
Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
|
Administrert SC
Andre navn:
|
|
Eksperimentell: Part A: LY900014 Test C
Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.
|
Administrert SC
Andre navn:
|
|
Eksperimentell: Part A: LY900014 Test D
Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
|
Administrert SC
Andre navn:
|
|
Eksperimentell: Part B: LY900014
Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.
|
Administrert SC
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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).
|
Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
|
|
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
|
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.
|
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
|
|
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
|
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.
|
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
|
|
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
|
Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Faktiske)
1. april 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
11. desember 2014
Først innsendt som oppfylte QC-kriteriene
11. desember 2014
Først lagt ut (Anslag)
16. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mai 2020
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15645
- I8B-FW-ITRA (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Friske Frivillige
-
Universidade do PortoFundação para a Ciência e a TecnologiaRekrutteringHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
Universidad Católica del MauleFullført
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of LeicesterNational Institute for Health Research, United KingdomFullførtPasienter med hjertesvikt og bevart ejeksjonsfraksjon - HFpEF | Pasienter med hjertesvikt med redusert ejeksjonsfraksjon - HFrEF | Healthy Controls Group - alders- og kjønnsmatchet
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvsluttetParkinsons sykdom | Healthy Controls Group - alders- og kjønnsmatchetFrankrike
Kliniske studier på LY900014
-
Eli Lilly and CompanyFullført
-
Eli Lilly and CompanyFullførtDiabetes mellitus, type 2Singapore
-
Eli Lilly and CompanyFullført
-
Eli Lilly and CompanyFullført
-
Eli Lilly and CompanyFullførtDiabetes mellitus, type 1Canada
-
Eli Lilly and CompanyFullførtType 2 diabetesForente stater, Puerto Rico
-
Eli Lilly and CompanyFullførtType 1 diabetesForente stater
-
Eli Lilly and CompanyFullført
-
Eli Lilly and CompanyFullførtType 1 diabetes mellitusCanada, Tyskland
-
Eli Lilly and CompanyFullførtDiabetes mellitus, type 1Tyskland