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A Study of LY2216684 in Healthy Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01373931
First received: June 13, 2011
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

This study involves a single dose of 18 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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: LY2216684
Drug: Ortho Cyclen
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of LY2216684 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: maximum plasma concentration (Cmax) of ethinyl estradiol, norelgestromin and LY2216694 [ Time Frame: Predose, up to 24 hours post dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: time to maximum plasma concentration (tmax) of ethinyl estradiol and norelgestromin [ Time Frame: Predose, up to 24 hours post dose ] [ Designated as safety issue: Yes ]
  • Area under the concentration-time curve over a dosing interval (AUCt) of ethinyl estradiol and norelgestromin [ Time Frame: Predose, up to 24 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OC + LY2216684 First, Then OC + Placebo
28 day Lead-in period of Ortho Cyclen (OC) (28 day packet), followed by randomization to OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days.
Drug: LY2216684
Administered orally
Drug: Ortho Cyclen
35 mcg ethinyl estradiol and 250 mcg norgestimate administered orally
Drug: Placebo
Administered orally
Experimental: OC + Placebo First, Then OC + LY2216684
28 day Lead-in period of Ortho Cyclen (OC) (28 day packet), followed by randomization to OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days.
Drug: LY2216684
Administered orally
Drug: Ortho Cyclen
35 mcg ethinyl estradiol and 250 mcg norgestimate administered orally
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373931

Locations
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01373931     History of Changes
Other Study ID Numbers: 12615, H9P-EW-LNCX
Study First Received: June 13, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014