A Study of LY2216684 in Healthy Females
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: LY2216684; Ortho Cyclen; Placebo
Intervention description: Administered orally; 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally; Administered orally
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by
      mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral
      contraceptive Ortho Cyclen®. This study will run approximately 93 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy females, as determined by medical history and physical examination

          -  As it is possible that LY2216684 may cause the oral contraceptive tablet to be less
             effective than usual, participants will be required in addition to use double barrier
             methods of contraception from the Screening until 2 months after the post study
             follow-up. Additional barrier methods of contraception may include the following: a
             non-hormonal intrauterine device with spermicide; female condom with spermicide;
             contraceptive sponge with spermicide; diaphragm with spermicide; cervical cap with
             spermicide; a male sexual partner who agrees to use a male condom with spermicide; a
             sterile sexual partner; or abstinence (participants reporting abstinence who become
             sexually active while on the study must agree to use other additional barrier methods
             of contraception). The pregnancy test result must be negative at Screening and at each
             Check-in

          -  Have a body weight of >50 kilograms (kg)

          -  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 for blood sampling as per the protocol

          -  Have normal blood pressure and pulse rate (sitting position) as determined by the
             investigator

          -  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 institutional review
             board (IRB) governing the site

        Exclusion Criteria:

          -  Are currently enrolled in, have completed or discontinued within the last 30 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 Ortho Cyclen, LY2216684, or related compounds

          -  Are participants who have previously completed or withdrawn from this study or any
             other study investigating LY2216684 within 6 months prior to Screening

          -  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 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

          -  Have a history or show evidence of significant active neuropsychiatric disease or have
             a history or suicide attempt or ideation

          -  Regular use of known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of human immunodeficiency virus infection (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 medication (other than the acceptable
             oral contraceptive allowed in this study and influenza vaccinations) within 14 days
             prior to dosing unless deemed acceptable by the investigator and sponsor's medical
             monitor

          -  Have donated blood of more than 500 milliliter (mL) prior to lead-in phase Check-in
             (Day -1)

          -  Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling
             to stop alcohol consumption for 48 hours prior to each Check-in to the clinical
             research unit (CRU) [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]

          -  Consume 5 or more cups of coffee (or other beverages of comparable caffeine content)
             per day, on a habitual basis, or any participants unwilling to adhere to study
             caffeine restrictions

          -  Use of any tobacco- or nicotine-containing products (including but not limited to
             cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or
             nicotine gum) within 6 months prior to the lead-in phase Check-in (Day -1) and during
             the study

          -  Have consumed grapefruit, starfruit, pomegranates, or products containing those items
             7 days prior to enrollment or are unwilling to avoid them during the study

          -  Have a documented or suspected history of glaucoma

          -  Participants that have taken injectable contraceptives within 12 months of enrollment
             to this study or topical controlled delivery contraceptives (patch) for 3 months prior
             to enrollment into this study

          -  The history or presence of any contraindications to the combined oral contraceptive
             tablet including thrombosis and the history of any thromboembolic disease, recurrent
             jaundice, acute or chronic liver disease, migraines, undiagnosed vaginal bleeding,
             significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or
             suspected)

          -  Participants determined to be unsuitable by the investigator for any reason