Clinical trial: A Study of Nociceptin/Orphanin FQ Peptide Receptor Occupancy in Healthy Subjects (NCT01404091)

Eligibility criteria:
Inclusion Criteria:

          -  Have a body mass index between 19.0 and 30.0 kilogram square meter (kg/m²), inclusive,
             weight less than 125.0 kilogram (kg), and physical dimensions which appear small
             enough to fit into the magnetic resonance imaging (MRI) and positron emission
             tomography scanners (PET)

          -  Must be in good health, as determined by a medical history, vital signs, physical
             examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

          -  Have venous and arterial access sufficient to allow blood sampling

          -  Are nonsmokers for at least 3 months prior to Screening, according to self report
             (meaning zero cigarettes smoked)

          -  Have a calculated creatinine clearance of greater than (>)70 milliliters per minute
             (mL/min) at Screening

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  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 (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:

               -  Confirmed Bazett's corrected QT interval (QTcB) greater than (>) 450 milliseconds
                  (msec)

               -  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 interval
                  less than (<) 110 msec, confirmed by a repeat ECG other than mild first-degree 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 (cardiac
                  output) syndrome

               -  T wave configurations are not of adequate quality for assessing corrected QTc
                  intervals

          -  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
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction