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A Study of LY2216684 and Theophylline in Healthy Subjects

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); Theophylline (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 primary aim of this study is to confirm that LY2216684 is not an inhibitor of CYP1A2 in vivo using theophylline as a probe substrate for the enzyme. Since LY2216684 has been observed to increase heart rate in some healthy subjects, this study will also assess heart rate when co-administered with theophylline.

Clinical Details

Official title: Effect of LY2216684 on the Pharmacokinetics of Theophylline in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics, concentration maximum (Cmax) of Theophylline

Pharmacokinetics, time to concentration maximum (tmax) of Theophylline

Pharmacokinetics, area under the curve (AUC) of Theophylline

Secondary outcome: Change in Heart Rate

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are overtly healthy males or females, 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 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.

- Have venous access sufficient to allow blood sampling as per the protocol.

- Have normal sitting blood pressure and pulse rate 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 investigator site personnel directly affiliated with this study and their

immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

- 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, theophylline, 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 within 14 days prior to

dosing unless deemed acceptable by the investigator and Sponsor's medical monitor.

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

inhibitors of CYP1A2 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 for 48 hours prior to check-in in each 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 and chocolate 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 glaucoma.

- 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., Dallas, Texas, United States
Additional Information

Starting date: December 2010
Last updated: March 15, 2011

Page last updated: August 23, 2015

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