A Study of LY2963016 in Healthy Participants
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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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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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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- Are persons who have previously completed or withdrawn from this study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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
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Somministrato per via sottocutanea
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Sperimentale: 0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
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Somministrato per via sottocutanea
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Sperimentale: 0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
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Somministrato per via sottocutanea
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Sperimentale: 0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
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Somministrato per via sottocutanea
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 14676
- I4L-MC-ABEM (Altro identificatore: Eli Lilly and Company)
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