Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject
Condition: Insomnia
Intervention: LY2624803; Activated Charcoal
Intervention description: Administered orally (po), once.; Administered po
Intervention MeSH terms: Charcoal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of activated charcoal and dosing time on
      the absorption of LY2624803 in healthy subjects. In this crossover study, there are three
      treatments with a washout period of at least 7 days in between treatments. Each subject will
      participate in all three treatments with random assignment to the treatment sequence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination.

          -  Male subjects with female partners of child-bearing potential and female subjects of
             child-bearing potential, agree to use 2 reliable methods of contraception from the
             time of the first dose until 3 months after the last dose of study drug or are women
             not of child-bearing potential due to postmenopausal or permanently sterilized [for
             example, tubal occlusion, hysterectomy, bilateral salpingectomy]).

          -  Have a body mass index (BMI) between 18.5 and 32 kilograms per square meter (kg/m2),
             inclusive, and a body weight of 50 kg or above at screening.

          -  Have clinical laboratory test results within normal reference range for the population
             or investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator.

          -  Have venous access sufficient to allow blood sampling as per the protocol.

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures.

          -  Have given written informed consent approved by Lilly and the ethical review board
             governing the site.

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 90 days from, a clinical
             trial involving an investigational drug or device or off-label use of a drug or device
             (other than the study drug 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 LY2624803 or related compounds.

          -  Are persons who have previously completed or withdrawn from this study or any other
             study investigating LY2624803.

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study.

          -  Have an abnormal blood pressure as determined by the investigator.

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal (except appendectomy), endocrine, hematological, dermatological,
             venereal, 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 or history of postural hypotension, loss of consciousness, explained or
             unexplained syncope or seizure episodes or a family history of seizures. A history of
             a single febrile convulsion is acceptable.

          -  Show evidence of significant active neuropsychiatric disease.

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening.

          -  Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV
             antibodies.

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody.

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen.

          -  Are women with a positive pregnancy test or women who are lactating.

          -  Intend to use over-the-counter or prescription medications, with the exception of
             vitamins and paracetamol, which cannot be safely discontinued within 7 days prior to
             admission.

          -  Have donated blood of more than 500 milliliters (mL) within the last 3 months prior to
             screening.

          -  Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21
             units per week (females), and are subjects unwilling to stop alcohol consumption from
             48 hours prior to admission until discharge from the unit for each treatment period,
             and to limit alcohol intake to a maximum of 2 units/day between treatment periods.

          -  Have a history of breast cancer.

          -  Are subjects with excessive xanthine consumption.

          -  Exhibit any other condition, which, in the opinion of the investigator would preclude
             participation in the study.