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About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
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:
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).
The following exclusion criteria apply only to those subjects enrolling in the part of the study involving lumbar puncture (LP) procedures
Primary purpose
Allocation
Interventional model
Masking
66 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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