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Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects

15 mei 2017 bijgewerkt door: Eli Lilly and Company

Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Male Subjects

This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

6

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • Overtly healthy males, as determined by medical history and physical examination
  • Will either be sterile or, if sexually active, agree to use a reliable method of birth control from check-in until 3 months after the end of the study
  • Body mass index (BMI) between 19 and 30 kilogram/square meter (kg/m²)
  • Experience on average 1 to 2 bowel movements per day
  • Clinical laboratory test results within the normal reference range for the clinical research unit (CRU) or, results with acceptable deviations which are judged to be not clinically significant by the investigator
  • Normal blood pressure and heart rate (sitting) as determined by the investigator
  • Venous access sufficient to allow blood sampling
  • Are reliable and willing to make themselves available for the duration of the study, and are willing to abide by the CRU policies and procedures, and study restrictions
  • Have given written informed consent approved by Lilly and the Institutional Review Board (IRB) governing the CRU

Exclusion Criteria:

  • Are currently enrolled in, have completed or discontinued, a clinical trial involving an investigational product 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 LY3009104, related compounds, or any components of the formulation
  • Have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY3009104
  • History or presence of an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant
  • Current or recent history (<30 days prior to Screening and/or <45 days prior to Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
  • An Absolute Neutrophil Count (ANC) less than 2000 cells/microliter. For abnormal values a single repeat will be allowed
  • Have a history or presence of 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 and in particular evidence of significant medical or psychiatric illness within the past 12 months
  • Have known substance dependence or abuse within 6 months prior to the study (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Evidence hepatitis B (active or surface antigen positive [HBsAg+]) or hepatitis B core antibody positive, hepatitis B surface antibody negative (HBcAb+, HBsAb-)
  • Use of prescription medication; over-the-counter medication; or herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission
  • Consumption of grapefruit or grapefruit-containing foods or juices within 7 days prior to dosing or at any time during the study
  • Have an average weekly alcohol intake that exceeds 15 units per week, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any subjects unwilling to adhere to study caffeine restrictions (no caffeine 48 hours prior to admission until the end of study
  • Use of tobacco or nicotine-replacement products within the 6 months prior to study entry or at any time during the study
  • Have donated blood of more than 500 mL within the last month
  • Have participated in a 14C-study within the last 6 months prior to Check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), for example less than 5,000 millirem (mrem)/year whole body annual exposure
  • Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LY3009104
Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
Oraal toegediend
Andere namen:
  • Baricitinib

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces
Tijdsspanne: Baseline up to 120 hours
Baseline up to 120 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
Tijdsspanne: Baseline up to 48 hours
Baseline up to 48 hours
Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
Tijdsspanne: Baseline up to 48 hours
Baseline up to 48 hours
Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)
Tijdsspanne: Baseline up to 48 hours
Baseline up to 48 hours
Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)
Tijdsspanne: Baseline up to 48 hours
Baseline up to 48 hours
Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)
Tijdsspanne: Baseline up to 48 hours
Baseline up to 48 hours
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
Tijdsspanne: Baseline up to 48 hours
Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.
Baseline up to 48 hours
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces
Tijdsspanne: Baseline up to 72 hours
Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.
Baseline up to 72 hours
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
Tijdsspanne: Baseline up to 24 hours
Baseline up to 24 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon - Fri, 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2011

Primaire voltooiing (Werkelijk)

1 maart 2011

Studie voltooiing (Werkelijk)

1 maart 2011

Studieregistratiedata

Eerst ingediend

16 februari 2011

Eerst ingediend dat voldeed aan de QC-criteria

16 februari 2011

Eerst geplaatst (Schatting)

18 februari 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2017

Laatste update ingediend die voldeed aan QC-criteria

15 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 14010
  • I4V-MC-JADG (Andere identificatie: Eli Lilly and Company)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Gezonde vrijwilligers

Klinische onderzoeken op LY3009104

3
Abonneren