A Study of LY2216684 in Healthy Females



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 45
Updated:10/25/2018
Start Date:June 2011
End Date:December 2011

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Effect of LY2216684 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

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.


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
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