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A Study to Evaluate the Effect of Genotype on LY2216684

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: Depressive Disorder, Major

Intervention: LY2216684 (Drug); Quinidine (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 study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented.

Clinical Details

Official title: A Study to Investigate the Effect of CYP2C19 Phenotype on the Pharmacokinetics of LY2216684 in Healthy Subjects

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

Primary outcome:

Pharmacokinetics: Area under the plasma concentration-time curve from time 0 to infinity [AUC(0-∞)] of LY2216684 in cytochrome P450 (CYP)2C19 extensive metabolizers (EM) versus poor metabolizers (PM)

Pharmacokinetics: Maximum observed plasma concentration (Cmax) of LY2216684 in cytochrome P450 (CYP)2C19 extensive metabolizers (EM) versus poor metabolizers (PM)

Pharmacokinetics: Time to maximum observed plasma concentration (tmax) in cytochrome P450 (CYP)2C19 extensive metabolizers (EM) versus poor metabolizers (PM)

Secondary outcome:

Pharmacokinetics: Area under the plasma concentration-time curve from time 0 to infinity [(AUC(0-∞)] of LY2216684 + Quinidine in cytochrome P450 (CYP)2C19 poor metabolizers (PM)

Pharmacokinetics: Maximum observed plasma concentration (Cmax) of LY2216684 + Quinidine in CYP2C19 poor metabolizers

Pharmacokinetics: Time to maximum observed plasma concentration (tmax)in CYP2C19 poor metabolizers

Eligibility

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

Criteria:

Inclusion Criteria:

- Are overtly healthy males or females, as determined by medical history and physical

examination

- Male participants: Agree to use a reliable method of birth control during the study

and for 1 month following the last dose of study drug

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

pregnancy at the time of enrollment, have used a reliable method of birth control (not including hormonal contraceptives) for 4 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 the study drug or; Are women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] level >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

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

- 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

- Have normal blood pressure (BP) and pulse rate (PR) (sitting position) as determined

by the investigator

- Are predicted to have cytochrome P450 (CYP)2C19 extensive metabolizer (EM) or poor

metabolizer (PM) phenotypes as determined by genotyping assessment

- Are predicted to have CYP2D6 EM phenotype as determined by genotyping assessment.

Exclusion Criteria:

- Are currently enrolled in, have completed or discontinued within the last 30 days

from, a clinical trial involving an investigational product; 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/intolerance to LY2216684 or quinidine, related compounds, or any

components of the formulation

- Are persons who have previously received the investigational product in this study,

have 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 show evidence of significant active neuropsychiatric disease or

have a history of suicide attempt or ideation

- 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

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

screening

- Show evidence of human immunodeficiency virus (HIV) infection 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 or during the study unless deemed acceptable by the investigator and Sponsor's medical monitor. Exceptions include influenza vaccinations, the use of topical medication (provided there is no evidence of chronic dosing with the risk of systemic exposure), occasional use of acetaminophen/paracetamol/ibuprofen, and hormone replacement therapy including thyroid replacement (stable dose for at least 1 month).

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

- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14

units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing in Period 1 until Discharge (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)

- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the

study

- 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 stop caffeine consumption from 48 hours prior to dosing in Period 1 until Discharge

- Have consumed grapefruit or grapefruit-containing products 30 days prior to

enrollment or unwilling to abstain during the study

- Have a documented or suspected history of glaucoma

- Participants unwilling to adhere to the smoking restrictions of the Clinical Research

Unit (CRU) while a resident of the CRU

- Use of known inhibitors and/or inducers of CYP2C19 and CYP2D6 (with the exception of

quinidine per protocol) 30 days prior to enrollment or are unwilling to avoid them during the study.

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: October 2011
Last updated: November 1, 2012

Page last updated: August 23, 2015

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