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A Study of LY2963016 in Healthy Participants

3 oktober 2014 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

24

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • 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.

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

21 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
Administreras subkutant
Experimentell: 0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
Administreras subkutant
Experimentell: 0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
Administreras subkutant
Experimentell: 0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
Administreras subkutant

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
Tidsram: Predose up to 24 hours after administration of study drug
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.
Predose up to 24 hours after administration of study drug
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
Tidsram: Predose up to 24 hours after administration of study drug
Predose up to 24 hours after administration of study drug

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
Tidsram: Predose up to 24 hours after administration of study drug
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.
Predose up to 24 hours after administration of study drug
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
Tidsram: Predose up to 24 hours after administration of study drug
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.
Predose up to 24 hours after administration of study drug
Maximum Glucose Infusion Rate (Rmax)
Tidsram: Postdose up to 24 hours after administration of study drug
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.
Postdose up to 24 hours after administration of study drug
Total Amount of Glucose Infused (Gtot)
Tidsram: Postdose up to 24 hours after administration of study drug
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.
Postdose up to 24 hours after administration of study drug

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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

1 juli 2012

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 september 2012

Studieregistreringsdatum

Först inskickad

2 juli 2012

Först inskickad som uppfyllde QC-kriterierna

2 juli 2012

Första postat (Uppskatta)

6 juli 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 oktober 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 oktober 2014

Senast verifierad

1 oktober 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 14676
  • I4L-MC-ABEM (Annan identifierare: Eli Lilly and Company)

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Kliniska prövningar på Friska volontärer

Kliniska prövningar på LY2963016

3
Prenumerera