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A Study of the Effect of LY2216684 on Lorazepam

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: LY2216684 (Drug); Placebo (Drug); Lorazepam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to determine how much lorazepam gets into the blood and how long it takes the body to get rid of it when given together with LY2216684. Information about any side effects that may occur will also be collected.

Clinical Details

Official title: Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of Lorazepam in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics of lorazepam, maximum plasma concentration (Cmax).

Pharmacokinetics of lorazepam, time to maximum plasma concentration (tmax)

Pharmacokinetics of lorazepam, area under the plasma concentration curve (AUC) from time 0 to ∞.

Secondary outcome: Change from baseline in cognitive function.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are overtly healthy, as determined by medical history and physical examination.

- Male subjects - Agree to use a reliable method of birth control during the study and

for 1 month following the last dose of study drug.

- Female subjects - Are women of child-bearing potential who test negative for

pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mIU/mL).

- Have a body weight >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 (potassium, magnesium, and calcium values must be within the normal range).

- Have venous access sufficient to allow 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 ethical review board

(ERB) governing the site. Exclusion Criteria:

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical

trial involving an investigational drug or device or off-label use of a drug or device other than the study drug, 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 LY2216684, lorazepam, benzodiazepines, 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 ECG that, in the opinion of the investigator,

increases the risks associated with participating in the study.

- Have a history of or current 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 of suicide attempt or ideation.

- Regularly use known drugs of abuse and/or show positive findings on urinary drug

screening.

- Show evidence of human immunodeficiency virus (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 (including hormonal

contraceptives) within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor, except for influenza vaccinations.

- Use of any drugs or substances that are known to be substrates, inducers, or

inhibitors of UGT within 30 days prior to dosing.

- Have donated blood of more than 500 mL within the last month.

- Have an average weekly alcohol intake that exceeds 14 units per week, or are

unwilling to stop alcohol consumption 48 hours prior to each study period and while resident at the 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.

- Have used any tobacco-containing 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 enrollment.

- Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment

and during the study.

- Have a documented or suspected history of acute narrow angle glaucoma.

- Have Gilbert's Syndrome

- Subjects determined to be unsuitable by the investigator for any reason.

Locations and Contacts

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., Evansville, Indiana, United States
Additional Information

Starting date: December 2010
Last updated: April 14, 2011

Page last updated: August 23, 2015

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