A Study of LY2940094 in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01263236
First received: December 16, 2010
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of LY2940094 in healthy male subjects.


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2940094
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of LY2940094 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of LY2940094, maximal concentration (Cmax)- single dose [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- single dose [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2940094, maximal concentration (Cmax) - multiple dose [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- multiple dose [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2940094 - single dose
single oral dose of 2-200mg LY2940094
Drug: LY2940094
Administered orally
Experimental: LY2940094 - multiple
oral daily dose of 2-200 mg LY2940094 for 7 days
Drug: LY2940094
Administered orally
Experimental: Placebo
single oral dose or daily dose for 7 days
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males of any ethnic origin.
  • Have a body mass index (BMI) between 19.0 and 30.0 kilogram/square meter (kg/m^2), inclusive.
  • Must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations.
  • Have a calculated creatinine clearance of greater than 70 milliliter/minute (mL/min).
  • Have venous access sufficient to allow blood sampling as per the protocol.
  • Will have given their written informed consent to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

  • Male subjects who are not, or whose partners are not willing to use appropriate contraception from the time of the first dose until 3 months after the final dosing occasion.
  • Have received any prescribed systemic or topical medication within 14 days of the first dose administration
  • Have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
  • Have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
  • 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 donated or lost 50 to 499 milliliter (mL) of whole blood within 30 days, or more than 499 milliliter (mL) whole blood within 56 days preceding first dose administration.
  • Have a significant history of drug allergy as determined by the Investigator.
  • Have any clinically significant allergic disease (excluding non-active hay fever), or any known allergy to LY2940094 or excipients as determined by the Investigator.
  • Have a semi-reclined blood pressure and pulse rate higher than 130/90 millimeters of mercury (mmHg) and 100 beats per minute (bpm), respectively, or lower than 90/50 millimeters of mercury (mmHg) and 40 beats per minute (bpm), respectively.
  • Consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse/dependence as determined by the Investigator.
  • Have a positive urine drug screen or alcohol breath test result that indicates substance abuse at screening or at admission to any treatment period.
  • Smoke more than 10 cigarettes or the equivalent in tobacco per day and willing to avoid smoking for durations of at least 10 hours.
  • With, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
  • Have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
  • Have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for human immunodeficiency virus (HIV) antibodies.
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risk of participating in the study. In addition, subjects with the following findings will be excluded:

    • Confirmed Bazett's corrected QT (QTcB) interval greater than 450 millisecond (msec) in 2 of 3 electrocardiograms (ECGs).
    • Bundle branch blocks and other conduction abnormalities (including 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolffe-Parkinson-White Syndrome, defined as PR less than 110 milliseconds (msec),confirmed by a repeat electrocardiogram [ECG]) other than mild first-degree atrioventricular block (AV) block.
    • Irregular rhythms other than sinus arrhythmia or occasional rare supraventricular ectopic beats.
    • History of unexplained syncope.
    • Family history of unexplained syncope or sudden death due to long QT syndrome.
    • T wave configurations are not of adequate quality for assessing QTc intervals.
  • Have previously completed or been withdrawn from this study.
  • Taking any excluded medications that cannot be discontinued at Screening.
  • Have a personal or family history of recurrent seizures or complicated febrile seizures.
  • Have a history of significant brain trauma.
  • Have epileptiform activity on baseline electroencephalogram (EEG).
  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: NCT01263236

Locations
Canada, Ontario
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.
Toronto, Ontario, Canada, M5V 2T3
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: NCT01263236     History of Changes
Other Study ID Numbers: 14095, I5J-MC-NOAA
Study First Received: December 16, 2010
Last Updated: November 11, 2011
Health Authority: Canada: Health Canada

Keywords provided by Eli Lilly and Company:
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014