This study involves a single dose of 18 mg LY2216684 taken as 2 tablets by mouth. The study
will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive Ortho
CyclenŽ. This study will run approximately 93 days.
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 (OC) tablet to be
less effective than usual, subjects 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 (subjects 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 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- Are persons who have previously completed or withdrawn from this study or any other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 (OC) 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 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 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 subjects 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
- Subjects 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
(OC) 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)
- Subjects determined to be unsuitable by the investigator for any reason
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
