A Study of LY2940094 in Major Depressive Disorder
This study has been completed.
Sponsor:
Eli Lilly and Company
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 June 18, 2013