A Study of LY2216684 and Digoxin in Healthy Subjects

NCT01266590 | Completed Phase 1 Results

• 2 other identifiers: 12600H9P-EW-LNCK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)

  Cmax of digoxin when administered alone and when co-administered with LY2216684.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14

• Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)

  Tmax of digoxin when administered alone and when co-administered with LY2216684.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14

• Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)

  AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14

Study Arms (1)

LY2216684 + digoxin

EXPERIMENTAL

Two oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14.

Drug: LY2216684; Drug: Digoxin

Interventions

LY2216684 DRUG

Administered orally

LY2216684 + digoxin

Digoxin DRUG

Administered orally

LY2216684 + digoxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are overtly healthy, 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 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 \[FSH\] greater than (\>) 40 milli-International Units/milliliter (mIU/mL).
• Have a body weight \>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 (potassium, magnesium, and calcium values must be within the normal range).
• Have normal renal function defined as an estimated creatinine clearance of at least 80 milliliters/minute (mL/min) as calculated with the Cockcroft-Gault equation.
• 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.

You may not qualify if:

• 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, digoxin, 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 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 of significant dysrhythmias or atrioventricular (AV) block.
• 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 P-glycoprotein (P-gp) and Cytochrome (P45) (CYP) within 30 days prior to dosing.
• Have donated blood of more than 500 milliliters (mL) within the last month.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Daytona Beach, Florida, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol; Digoxin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 24, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-03

Locations

US (1)