Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
Condition: Healthy Volunteers
Intervention: LY3009104
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Absorption; Distribution; Metabolism; Excretion; Mass balance; Metabolic profile; Radiolabeled study; 14C

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.
    

Eligibility criteria:

        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)