NCT01263236

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 major-depressive-disorder

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

December 16, 2010

Last Update Submit

February 1, 2017

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • Number of participants with clinically significant effects

    Baseline to study completion

Secondary Outcomes (4)

  • Pharmacokinetics of LY2940094, maximal concentration (Cmax)- single dose

    Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose

  • Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- single dose

    Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose

  • Pharmacokinetics of LY2940094, maximal concentration (Cmax) - multiple dose

    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

  • Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- multiple dose

    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

Study Arms (3)

LY2940094 - single dose

EXPERIMENTAL

Single oral dose of 2-800 milligram (mg) LY2940094

Drug: LY2940094

LY2940094 - multiple dose

EXPERIMENTAL

Daily oral dose of 2-200 mg LY2940094 for 14 days

Drug: LY2940094

Placebo

EXPERIMENTAL

Single oral dose or daily oral dose for 14 days

Drug: Placebo

Interventions

LY2940094DRUG

Administered orally

LY2940094 - multiple doseLY2940094 - single dose
PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males of any ethnic origin.
  • Have a body mass index (BMI) between 19.0 and 30.0 kilogram/square meter (kg/m²), 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.

You may not qualify if:

  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

LY2940094

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 20, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

CA(1)