LY2189265 and Atorvastatin Interaction Study
Condition: Healthy Volunteers
Intervention: Atorvastatin; LY2189265
Intervention description: Administered orally.; Administered subcutaneously.
Intervention MeSH terms: Dulaglutide; Atorvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess if giving LY2189265 at the same time as atorvastatin affects how the
      body absorbs atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects with female partners of child-bearing potential: Agree and whose
             partners agree to use two reliable methods of contraception from the time of the first
             dose until 3 months after the last dose of study drug, as determined by the
             investigator.

          -  Female subjects not of child-bearing potential (that is, are postmenopausal or
             permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral
             salpingectomy]) will not be required to use contraception. Postmenopausal is defined
             as at least 1 year post cessation of menses (without an alternative medical cause)
             with follicle stimulating hormone (FSH) greater than or equal to 40 milliInternational
             Units per milliliter (mIU/mL).

          -  Female subjects who have undergone sterilization by tubal ligation: Agree to use a
             male or female condom used in conjunction with spermicidal gel, foam, cream, film or
             suppository from the time of screening until 3 months after the last dose of study
             drug. Such subjects must also test negative for pregnancy at the time of enrollment.

          -  Have a body mass index (BMI) between 18.5 and 30.0 kilograms per square meter
             (kg/m^2), inclusive.

          -  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 frequent blood sampling.

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow the study restrictions

        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
             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 or intolerance to atorvastatin.

          -  Have known allergies to glucagon-like peptide-1 (GLP-1)-related compounds including
             LY2189265.

          -  Are persons who have previously completed or withdrawn from this study, or have taken
             part in any other study investigating LY2189265 or GLP-1-related compounds or incretin
             mimetics within the last 3 months.

          -  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 (after at least 5 minutes sitting) that, in the
             opinion of the investigator, increases the risks associated with participating in the
             study.

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis) or gastrointestinal disorder, for example esophageal
             reflux or gall bladder disease, or any gastrointestinal disease which impacts
             absorption and distribution of study drugs (for example, gastric bypass surgery,
             pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1
             analogs.

          -  Have a history or presence of thyroid disease.

          -  Show history or 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.

          -  Intend to use over-the-counter medication within 7 days prior to dosing or
             prescription medication (with the exception of vitamin/mineral supplements and/or
             hormone replacement therapy) within 14 days prior to dosing.

          -  Use drugs that are known substrates, inducers, or inhibitors of cytochrome P450 (CYP)
             enzyme pathways or phosphorylated glycoprotein (P-gp) within 14 days prior to the
             first dose.

          -  Have donated blood of more than 500 mL within the month prior to screening.

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females), and are subjects unwilling to stop alcohol consumption from
             48 hours before Admission (Day -1) until discharge from the unit for each treatment
             period, and to limit alcohol intake to a maximum of 2 units/day on all other days from
             screening through 48 hours prior to the post-study visit (1 unit = 12 ounces (oz) or
             360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).

          -  Are subjects who, in the opinion of the investigator, are in any way unsuitable to
             participate in the study.

          -  Are women of child bearing potential