Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g. cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
Provide written informed consent before initiation of any study procedures
Available for follow-up for the planned duration of the study
Able to communicate well with the investigators
Able to adhere to the study protocol schedule, study restrictions and examination schedule
Subjects who are within their ideal body weight (BMI between >17 and =28 kg/m2)
Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
Subjects have no history of the following: ongoing acute or intermittent pain, postoperative pain, respiratory compromise, acute or severe asthma, or constipation (less than 1 bowel movement every 2 days)
Negative urine drug screening test at the time of screening
Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, ALT (liver function), AST (liver function) and bilirubin
Have normal screening laboratories for urine protein and urine glucose
Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year [no bleeding for 12 consecutive months], or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of the first day of each study session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or a vasectomized parter
Agrees not to participate in another clinical study/trial during the study period or to participate in an investigational drug study for at least one month after last study session
Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last study day
Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
Temperature 35-37.9°C (95-100.3°F)
Systolic blood pressure 90-140 mmHg
Diastolic blood pressure 60-90 mmHg
Heart rate 55-100 beats per minute
Respiration rate 12-18 breaths per minute

NCT02531971_inc_T1
Person
Men
NCT02531971_inc_T2
Person
women
NCT02531971_inc_T3
Qualifier
non-pregnant
NCT02531971_inc_T4
Person
age
NCT02531971_inc_T5
Value
18 and 45 years old
NCT02531971_inc_T6
Person
non-smokers
NCT02531971_inc_T11
Measurement
BMI
NCT02531971_inc_T12
Value
between >17 and =28 kg/m2
NCT02531971_inc_T14
Condition
pain
NCT02531971_inc_T15
Qualifier
acute
NCT02531971_inc_T16
Qualifier
intermittent
NCT02531971_inc_T17
Scope
acute or intermittent
NCT02531971_inc_T18
Condition
pain
NCT02531971_inc_T19
Qualifier
postoperative
NCT02531971_inc_T20
Condition
respiratory compromise
NCT02531971_inc_T21
Condition
asthma
NCT02531971_inc_T22
Qualifier
acute
NCT02531971_inc_T23
Qualifier
severe
NCT02531971_inc_T24
Negation
no
NCT02531971_inc_T25
Scope
acute or severe
NCT02531971_inc_T26
Condition
constipation
NCT02531971_inc_T27
Scope
acute or intermittent pain, postoperative pain, respiratory compromise, acute or severe asthma, or constipation
NCT02531971_inc_T28
Measurement
urine drug screening test
NCT02531971_inc_T29
Value
Negative
NCT02531971_inc_T30
Value
normal
NCT02531971_inc_T31
Measurement
white blood cells
NCT02531971_inc_T32
Measurement
WBC
NCT02531971_inc_T33
Measurement
hemoglobin
NCT02531971_inc_T34
Measurement
Hgb
NCT02531971_inc_T35
Measurement
platelets
NCT02531971_inc_T36
Measurement
sodium
NCT02531971_inc_T37
Measurement
potassium
NCT02531971_inc_T38
Measurement
chloride
NCT02531971_inc_T39
Measurement
bicarbonate
NCT02531971_inc_T40
Measurement
blood urea nitrogen
NCT02531971_inc_T41
Measurement
BUN
NCT02531971_inc_T42
Measurement
creatinine
NCT02531971_inc_T43
Measurement
ALT
NCT02531971_inc_T44
Measurement
AST
NCT02531971_inc_T45
Measurement
bilirubin
NCT02531971_inc_T46
Scope
white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, ALT (liver function), AST (liver function) and bilirubin
NCT02531971_inc_T47
Value
normal
NCT02531971_inc_T48
Measurement
urine protein
NCT02531971_inc_T49
Measurement
urine glucose
NCT02531971_inc_T50
Scope
urine protein and urine glucose
NCT02531971_inc_T54
Measurement
ECG
NCT02531971_inc_T55
Value
normal
NCT02531971_inc_T56
Negation
not
NCT02531971_inc_T57
Observation
pathologic Q wave abnormalities
NCT02531971_inc_T58
Observation
ST-T wave changes
NCT02531971_inc_T59
Condition
left ventricular hypertrophy
NCT02531971_inc_T60
Condition
right bundle branch block
NCT02531971_inc_T61
Condition
left bundle branch block
NCT02531971_inc_T62
Scope
pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block.
NCT02531971_inc_T63
Measurement
Temperature
NCT02531971_inc_T64
Value
35-37.9°C
NCT02531971_inc_T65
Value
95-100.3°F
NCT02531971_inc_T66
Measurement
Systolic blood pressure
NCT02531971_inc_T67
Value
90-140 mmHg
NCT02531971_inc_T68
Measurement
Diastolic blood pressure
NCT02531971_inc_T69
Value
60-90 mmHg
NCT02531971_inc_T70
Measurement
Heart rate
NCT02531971_inc_T71
Value
55-100 beats per minute
NCT02531971_inc_T72
Measurement
Respiration rate
NCT02531971_inc_T73
Value
12-18 breaths per minute