Assessment of Nociceptin/Orphanin FQ Peptide Receptor Occupancy After Single Oral Doses of LY2940094 as Measured by Positron Emission Tomography With the Radioligand LY2959530 in Healthy Subjects
Assessment of Nociceptin/Orphanin FQ Peptide Receptor Occupancy After Single Oral Doses of LY2940094 as Measured by Positron Emission Tomography With the Radioligand LY2959530 in Healthy Subjects
The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide (NOP) receptor occupancy (RO) in healthy subjects.
Inclusion Criteria:
Exclusion Criteria:
Male subjects who are not, or whose partners are not willing to use appropriate contraception (condom with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after dosing
Have received any prescribed systemic or topical medication within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
Have used any nonprescribed 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 unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
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 mL of whole blood within 30 days, or more than 499 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 nonactive hay fever), or any known allergy to LY2940094 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, respectively, or lower than 90/50 mmHg and 40 beats per minute, respectively
Consume more than 14 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse/dependence as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
Have a positive urine drug screen or alcohol breath test result that indicates substance abuse at screening or at admission to any treatment period
With, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator
With, or with a history of, any psychiatric illness as assessed with the Symptom Checklist (SCL-90R)
Have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
Have serum hepatitis (B or C), or who are carriers of the hepatitis B surface antigen 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 or any other study investigating LY2940094
Subjects who, in the opinion of the Investigator, should not participate in the study
Taking any excluded medications that cannot be discontinued at admission to the clinical research unit (CRU)
Have a personal or family history of recurrent seizures or complicated febrile seizures
Have a history of a significant brain condition/trauma
Indicates presence of suicidal ideation by answering "yes" to either of the first two questions on the baseline version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
Have any contraindication to magnetic resonance imaging (MRI) , such as implanted or embedded metal objects or fragments in the head or body that would present a risk during the magnetic resonance imaging (MRI) scanning procedure, or have worked with ferrous metal either as a vocation or hobby (for example, as a sheet metal worker, welder or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
Have had exposure to ionizing radiation in a research study that, in combination with the study tracer, would result in a cumulative exposure that exceeds recommended exposure limits of greater than (>) 20 millisieverts (mSv) in 1 year
Suffer from claustrophobia and would be unable to tolerate the confined spaces of magnetic resonance imaging (MRI) or positron emission tomography (PET) camera as evidenced by claustrophobia screening
Without a minimum of 37 inches (112 centimeters [cm] ) from the top of the head to the end of the wrist so as to allow reasonable access to the wrist to take a blood sample during the positron emission tomography (PET) scan
Have a significant history of hypersensitivity reactions to gelatin capsules.
Any other condition which, in the opinion of the investigator, would preclude participation in the study