A Study of LY2140023 in Healthy Participants
Condition: Healthy Volunteer Study
Intervention: LY2140023; Aqueous activated charcoal
Intervention MeSH terms: Charcoal
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will evaluate the effect of activated charcoal on absorption of LY2140023. The
      study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2
      times during study (once with activated charcoal, once without activated charcoal). This
      study will last approximately 16 days, not including screening. Screening is required within
      28 days prior to study entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are healthy males or females, as determined by medical history and physical
             examination

          -  male participants agree to use a reliable method of birth control during the study and
             for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3
             months following the last dose of LY2140023

          -  female participants:

               -  of childbearing potential, who test negative for pregnancy at screening and who
                  agree to use a reliable method of birth control during the study and for 3 months
                  following the last dose of LY2140023

               -  of non-childbearing potential; postmenopausal or permanently sterile following
                  hysterectomy, bilateral salpingectomy or confirmed tubal occlusion (not tubal
                  ligation). Postmenopausal is defined as spontaneous amenorrhea for at least 12
                  months, and a plasma follicle-stimulating hormone (FSH) level >40
                  milli-international units per milliliter(mIU/mL), unless the participant is
                  taking hormone replacement therapy

          -  have given written informed consent approved by Lilly and the chosen ethical review
             board (ERB)

        Exclusion Criteria:

          -  are currently enrolled in, have completed or discontinued within the last 90 days
             from, a clinical trial involving an investigational product other than the
             investigational product used in this study; 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 LY2140023 or LY404039, related compounds, activated charcoal,
             or any components of the formulation

          -  are participants who have previously withdrawn from this study or any other study
             investigating LY2140023 after receiving at least 1 dose of LY2140023

          -  show evidence or any history of significant active neuropsychiatric disease (for
             example, manic depressive illness, schizophrenia, depression)

          -  have increased risk of seizures based on a history of:

               -  one or more seizures (except for a single simple febrile seizure [lacking
                  focality and lasting less than 15 minutes, not associated with a central nervous
                  system (CNS) infection or severe metabolic disturbance] as a child between ages 6
                  months to 5 years)

               -  head trauma with loss of consciousness or a post-concussive syndrome within 1
                  year or lifetime history of head trauma with persistent neurological deficit
                  (focal or diffuse)

               -  CNS infection, uncontrolled migraine, or transient ischemic attack (TIA) within 1
                  year; stroke with persistent neurological deficit (focal or diffuse).
                  Uncontrolled migraine is defined as migraine attacks that produce headache
                  lasting up to 72 hours and are often accompanied by associated symptoms (nausea,
                  photophobia, and phonophobia) that impair well-being and disrupt social
                  functioning. TIA is defined as "mini-stroke" caused by temporary disturbance of
                  blood supply to an area of the brain, which results in a sudden, brief decrease
                  in brain function

               -  CNS infection with persistent neurological deficit (focal or diffuse)

               -  brain surgery

               -  electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated
                  spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank
                  seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally
                  defined)

               -  brain structural lesion, including developmental abnormalities, as determined by
                  examination or imaging studies (except hydrocephalus treated by shunt and without
                  neurological deficit)

          -  show evidence of active renal disease (for example, diabetic renal disease, polycystic
             kidney disease) or creatinine clearance less than 90 milliliters per minute (mL/min)
             as determined by the Cockroft Gault formula

          -  show evidence or any history of known substance dependence or abuse at any time
             (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV]
             diagnosis), or regularly use known drugs of abuse and/or show positive findings on
             urinary drug screening

          -  have a clinically significant abnormality in the neurological examination

          -  participants judged prior to randomization to be at suicidal risk by the investigator