- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01634165
A Study of LY2963016 in Healthy Participants
3. oktober 2014 oppdatert av: Eli Lilly and Company
Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.
The study will compare LY2963016 to Lantus at two different doses.
This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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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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:
- Healthy males or females
- Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
- Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
- Are nonsmokers and have not smoked for at least 6 months prior to entering the study
- Have normal blood pressures and pulse rates at screening, as determined by the investigator
- Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
- Have clinical laboratory test results within normal reference range for the population
- Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening
- Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Exclusion Criteria:
- Are persons who have previously completed or withdrawn from this study
- Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Show evidence of significant active neuropsychiatric disease
- Show evidence of current use of known drugs of abuse or have a history of use within the past year
- Have a history of first-degree relatives known to have diabetes mellitus
- Show evidence of an acute infection with fever or infectious disease at the time of study entry
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
- Have positive hepatitis B surface antigens at screening
- Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
- Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)
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 |
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Eksperimentell: 0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
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Administreres subkutant
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Eksperimentell: 0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
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Administreres subkutant
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Eksperimentell: 0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
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Administreres subkutant
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Eksperimentell: 0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
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Administreres subkutant
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
Tidsramme: Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
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Predose up to 24 hours after administration of study drug
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Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
Tidsramme: Predose up to 24 hours after administration of study drug
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Predose up to 24 hours after administration of study drug
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
Tidsramme: Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
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Predose up to 24 hours after administration of study drug
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Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
Tidsramme: Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
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Predose up to 24 hours after administration of study drug
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Maximum Glucose Infusion Rate (Rmax)
Tidsramme: Postdose up to 24 hours after administration of study drug
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Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
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Postdose up to 24 hours after administration of study drug
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Total Amount of Glucose Infused (Gtot)
Tidsramme: Postdose up to 24 hours after administration of study drug
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Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
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Postdose up to 24 hours after administration of study drug
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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. juli 2012
Primær fullføring (Faktiske)
1. september 2012
Studiet fullført (Faktiske)
1. september 2012
Datoer for studieregistrering
Først innsendt
2. juli 2012
Først innsendt som oppfylte QC-kriteriene
2. juli 2012
Først lagt ut (Anslag)
6. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. oktober 2014
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14676
- I4L-MC-ABEM (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. .
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