Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- A patient will be eligible for study participation if the subject meets the followingcriteria:
Voluntarily provide written informed consent to participate in the study prior to anystudy procedures.
Able to speak, read, and communicate clearly in English or Spanish; able to read andunderstand the study procedures.
Male or female between 21 and older at the time of Screening.
Scheduled for abdominal surgery (hysterectomy; prostatectomy; hemi-colectomy (including partial bowel resections) or ventral hernia repair) with no collateralprocedures.
Patient is categorized as American Society of Anesthesiologists (ASA) risk class of I,II or III.
Has a body mass index (BMI) within 18.0-40.0 kg/m2 and weight between 50 kg and 112kg, inclusive.
For women of childbearing potential- has a negative result on serum pregnancy testingat Screening and urine pregnancy test at Admission and does not currently breast feed,or is planning to do so within 30 days of receiving the last dose of study drug.
If female, the patient must be:
Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method with spermicide;condoms, any form of hormonal contraceptives; or abstinence from sexualintercourse) for 3 days following the last dose of study drug.
Of non-childbearing potential defined as surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or postmenopausalfor at least 1 year).
If male, the patient must be surgically or biologically sterile. If not sterile, thepatient must agree to use an acceptable form of birth control with heterosexualpartner (as described in inclusion criteria #8a) or abstain from sexual relations for 3 days following the last dose of study drug.
Is free of other physical, mental, or medical conditions, which, in the opinion of theInvestigator, would make study participation inadvisable.
Following surgery, the patient will be eligible for the second dose of study drug.
Exclusion
Exclusion Criteria: A patient will be excluded from the study if any of the following criteria are met:
Has a serum sodium level > 143 mmol/L at Screening.
Has a serum sodium level < 136 mmol/L at Screening.
Patient is unwilling or unable to comply with the study procedures and assessmentsuntil the end of the 48-hour treatment and observation period.
Has moderate to severe obstructive sleep apnea, which, in the opinion of theInvestigator is not being adequately treated (i.e., Nasal/Facial C-PAP), and will posean unacceptable risk.
Has known allergies or hypersensitivity to drugs that may be used during the study,including those used during the surgical procedure and in the post-operative period [e.g., inhaled anesthetics (such as sevoflurane), midazolam, opioids (such as fentanyland morphine sulfate), propofol or other sedatives, local anesthetics, antiemetics (such as ondansetron) non- steroidal anti-inflammatory drugs (such as ketorolac) oracetaminophen].
Uses antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents,selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants with a dosechange < 30 days prior to surgery.
Has a history or current diagnosis of substance dependence (except caffeine ornicotine) or alcohol abuse, according to the criteria of Diagnostic and StatisticalManual of Mental Disorders, Fifth Edition (DSM-5).
Has a positive urine drug screen for drugs of abuse at Screening.
Is unwilling to abstain from alcohol consumption for a period beginning 24 hours priorto Admission until the time of Discharge from the hospital.
Suffers from chronic dizziness, vestibular disorders, or has experienced severecontinuous diarrhea, retching, vomiting, or moderate or severe nausea and/or dizzinessfor any reason within 72 hours prior to Admission.
Has been diagnosed with a condition of hyperhidrosis (excessive sweating) or primaryhypodipsia (abnormally diminished thirst).
Has donated or had significant loss of whole blood (240 mL or more) within 30 days orplasma within 14 days prior to Admission.
Has a history (within 6 months) of clinically meaningful orthostatic changes in vitalsigns - OR - a decrease in systolic blood pressure by > 20 mm Hg or a decrease indiastolic blood pressure by 10 mm Hg together with an increase in heart rate of > 30beats per minute when transitioning from supine to standing measurements at the timeof Screening.
Hasmedicalconditions(e.g.,cardiovascular,pulmonary,hepatic,renal, hematologic,gastrointestinal, endocrine (adrenal hyperplasia), immunologic, dermatologic,neurologic, oncologic or psychiatric condition) or a significant laboratoryabnormality that, in the Investigator's opinion, would jeopardize the safety of thepatient or is likely to confound the study measurements.
Has congestive heart failure.
Has taken any diuretic medications within 2-weeks prior to the scheduled surgery.
Has an oxygen saturation < 92% on room air at Screening or Admission.
Has impaired renal function indicated by serum creatinine greater than 2 times thereference upper limit of normal (ULN).
Has a serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) greaterthan 2.5 times the reference upper limit of normal (ULN), or total bilirubin greaterthan 2 times the ULN at Screening.
Has, in the opinion of the Investigator, any clinical signs of dehydration orhypovolemia (e.g., symptomatic hypotension) or associated laboratory abnormalities,e.g., elevated hematocrit, elevated blood urea nitrogen (BUN) >1.5 x the reference ULNat Screening.
Has taken opioid analgesics for more than 10 consecutive days for any reason withinthe past 3 months prior to Screening.
Has taken opioid or non-opioid pain medication (e.g., NSAIDs such as naproxen,cyclooxygenase-2 inhibitors) within the 12 hours prior to surgery.
Has received another investigational drug within 30 days prior to Admission or hasplanned to participate in another clinical trial while enrolled in this study.
Study Design
Study Description
Connect with a study center
Cara Therapeutics Study Site
Sheffield, Alabama
United StatesSite Not Available
Cara Therapeutics Study Site
Phoenix, Arizona
United StatesSite Not Available
Cara Therapeutics Study Site
Los Angeles, California 90048
United StatesSite Not Available
Cara Therapeutics Study Site
New Haven, Connecticut
United StatesSite Not Available
Cara Therapeutics Study Site
Bradenton, Florida 34209
United StatesSite Not Available
Cara Therapeutics Study Site
Gainesville, Florida
United StatesSite Not Available
Cara Therapeutics Study Site
Maitland, Florida
United StatesSite Not Available
CCM Clinical Research Group
Miami, Florida
United StatesSite Not Available
Cara Therapeutics Study Site
Miami Gardens, Florida
United StatesSite Not Available
Cara Therapeutics Study Site
Pensacola, Florida 32503
United StatesSite Not Available
Cara Therapeutics Study Site
Saint Petersburg, Florida 33713
United StatesSite Not Available
Cara Therapeutics Study Site
Wellington, Florida
United StatesSite Not Available
Cara Therapeutics Study Site
Chicago, Illinois
United StatesSite Not Available
Cara Therapeutics Study Site
Boston, Massachusetts
United StatesSite Not Available
Cara Therapeutics Study Site
Jackson, Mississippi
United StatesSite Not Available
Cara Therapeutics Study Site
Camden, New Jersey 08103
United StatesSite Not Available
Cara Therapeutics Study Site
Neptune, New Jersey
United StatesSite Not Available
Cara Therapeutics Study Site
Neptune City, New Jersey
United StatesSite Not Available
Cara Therapeutics Study Site
Albany, New York 12208
United StatesSite Not Available
Cara Therapeutics Study Site
Stony Brook, New York
United StatesSite Not Available
Cara Therapeutics Study Site
Durham, North Carolina 27710
United StatesSite Not Available
Cara Therapeutics Study Site
Cincinnati, Ohio 45267
United StatesSite Not Available
Cara Therapeutics Study Site
Cleveland, Ohio
United StatesSite Not Available
Cara Therapeutics Study Site
Columbus, Ohio
United StatesSite Not Available
Cara Therapeutics Study Site
Pittsburgh, Pennsylvania
United StatesSite Not Available
Cara Therapeutics Study Site
Charleston, South Carolina 29425
United StatesSite Not Available
Cara Therapeutics Study Site
Chattanooga, Tennessee
United StatesSite Not Available
Cara Therapeutics Study Site
Bellaire, Texas
United StatesSite Not Available
Cara Therapeutics Study Site
Fort Worth, Texas
United StatesSite Not Available
Cara Therapeutics Study Site
Houston, Texas
United StatesSite Not Available
Cara Therapeutics Study Site
Plano, Texas
United StatesSite Not Available
Cara Therapeutics Study Site
San Antonio, Texas
United StatesSite Not Available
Cara Therapeutics Study Site
Salt Lake City, Utah 84124
United StatesSite Not Available
Cara Therapeutics Study Site
Madison, Wisconsin
United StatesSite Not Available
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