Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01299285
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 21, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 18, 2011
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date June 8, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces [ Time Frame: Baseline up to 120 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: Baseline up to 22 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] [ Time Frame: Baseline up to 48 hours ]
  • Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] [ Time Frame: Baseline up to 48 hours ]
  • Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax) [ Time Frame: Baseline up to 48 hours ]
  • Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax) [ Time Frame: Baseline up to 48 hours ]
  • Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax) [ Time Frame: Baseline up to 48 hours ]
  • Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine [ Time Frame: 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.
  • Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces [ Time Frame: 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.
  • Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma [ Time Frame: Baseline up to 24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • Plasma pharmacokinetics of LY3009104 and radioactivity, area under the concentration curve (AUC) [ Time Frame: Baseline up to 22 days ]
  • Plasma pharmacokinetics of LY3009104 and radioactivity, maximum concentration (Cmax) [ Time Frame: Baseline up to 22 days ]
  • Plasma pharmacokinetics of LY3009104 and radioactivity, time of maximum concentration (tmax) [ Time Frame: Baseline up to 22 days ]
  • Relative abundance of LY3009104 and the metabolites of LY3009104 in urine and feces [ Time Frame: Baseline up to 22 days ]
  • Relative abundance of LY3009104 and the metabolites of LY3009104 in plasma [ Time Frame: Baseline up to 22 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
Official Title  ICMJE Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Male Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: LY3009104
Administered orally
Other Name: Baricitinib
Study Arms  ICMJE Experimental: LY3009104
Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
Intervention: Drug: LY3009104
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2011)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01299285
Other Study ID Numbers  ICMJE 14010
I4V-MC-JADG ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP