A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Ortho-Cyclen; Dulaglutide
Intervention description: Administered orally; Administered subcutaneously
Intervention MeSH terms: Dulaglutide; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how the body processes oral contraceptive (OC), using
      Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female
      participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body.
      Information about any side effects that may occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are females of child-bearing potential, and who are overtly healthy as determined by
             medical history and physical examination

               -  As it is possible that dulaglutide may cause the oral contraceptive (OC) tablet
                  to be less effective than usual, participants will be required to use 2
                  additional highly effective methods of contraception from the screening
                  appointment until 2 months after the poststudy follow-up appointment. Additional
                  methods of contraception may include the following: a non-hormonal intrauterine
                  device with spermicide; male or female condom with spermicide; contraceptive
                  sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide;
                  sterile sexual partner; or abstinence (participants reporting abstinence who
                  become sexually active while on the study must agree to use other additional
                  methods of contraception). The pregnancy test result must be negative at
                  screening and at each check-in

          -  Have a body mass index (BMI) of between 18.5 and 30.0 kilogram-meter squared (kg/m^2),
             at screening

          -  Have no clinically significant findings, as determined by the investigator, upon
             bimanual pelvic and breast examinations, at screening (provision of previous
             gynecological examination documentation may be accepted)

          -  Have clinical laboratory test results within the 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

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures and restrictions

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) 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, 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, dulaglutide, or to related compounds or to any
             components of either formulation

          -  Are persons who have previously completed or withdrawn from this study or any other
             study investigating dulaglutide within 3 months prior to screening or have received
             glucagon-like peptides or incretin mimetics in the 3 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 an abnormal blood pressure (BP) (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 respiratory, hepatic, renal, 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 presence of cardiovascular disorder (including myocardial
             infarction, cerebrovascular accident, coronary artery disease, venous thromboembolism,
             arrhythmia [judged by the investigator to be clinically significant], or angina)
             within the last year, have symptoms or signs of congestive heart failure, or are
             expected to require coronary artery bypass surgery or angioplasty

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant
             esophageal reflux or gall bladder disease, or any gastrointestinal disease which
             impacts gastric emptying (GE) (such as, gastric bypass surgery, pyloric stenosis, with
             the exception of appendectomy) or could be aggravated by glucagon-like-peptide 1
             (GLP-1) analogs. Participants with dyslipidemia, and participants who had
             cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall
             bladder) in the past, with no further sequelae, may be included in the study at the
             discretion of the screening physician

          -  Show evidence of significant active neuropsychiatric disease

          -  Have family history of medullary thyroid cancer (MTC) or a genetic condition that
             predisposes to MTC

          -  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 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

          -  Have used or intend to use St John's Wort within 21 days of study drug administration
             or are unable/unwilling to adhere to the study drug restrictions

          -  Have donated blood of more than 500 milliliter (mL) within the last month prior to
             admission of the lead-in phase

          -  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 admission to the clinical
             research unit (CRU) and while resident at the CRU (1 unit = 12 ounce [oz] or 360 mL of
             beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

          -  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 admission into the lead-in phase

          -  Have taken injectable contraceptives or have used hormonal implants within 12 months
             of enrollment to this study or topical controlled delivery contraceptives (patch) or
             hormonal intrauterine devices (such as, Mirena® device) within 3 months prior to
             enrollment of this study

          -  The history or presence of any contraindications to the combined OC tablet including
             thrombosis and a history of thromboembolic disease, recurrent jaundice, acute or
             chronic liver disease, migraines, undiagnosed vaginal bleeding, significant
             hyperlipidemia, hepatic adenoma, and mammary, endometrial, or hepatic carcinoma or any
             other estrogen-dependent neoplasia (known or suspected)

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study