Ensayos clínicos

Inclusion Criteria:

• Male and female subjects, aged 18 – 65 years, inclusive.
• No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus.
• Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m^2 (BMI = weight (kg)/ [height (m)]^2).
• Subjects must agree to the following study restrictions: 
  • Males of procreative capacity (not surgically sterile) will use an acceptable method of contraception from randomization through 1 month following the last dose of study medication. Examples of acceptable contraception for males include abstinence, use of a barrier method, or sterilized or post-menopausal partner;
  • Females of child-bearing potential (not surgically sterile or post-menopausal, defined as 12 months without menses) will use an acceptable method of contraception from 1 month prior to randomization (or screening, if earlier) through 1 month following the last dose of study medication. Examples of acceptable methods of contraception for females include abstinence, double barrier method, IUD, hormonal contraception, or sterilized partner.
• Ability and acceptance to provide written informed consent.
• Willing to participate in the pharmacogenomics sample collection.
• Willing and able to comply with all study requirements and restrictions.
• Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria:

• Unable or unwilling to provide informed consent or to comply with study procedures.
• Unwilling to agree to provide pharmacogenomics sample.
• Diagnosis of gastrointestinal diseases.
• Structural or metabolic diseases that affect the GI system.
• Unable to avoid the following over-the-counter medications 48 hours prior to the receipt.
• of study medication and throughout the study:
  • Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin;
  • Analgesic drugs including NSAIDs and COX-2 inhibitors.
    • NOTE:  Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control are permissible. 
• History of recent surgery (within 60 days of screening).
• Pregnant or nursing.
• History of intolerance and/or hypersensitivity to medications similar to tradipitant and its accompanying excipients.
• History (including family history) or current evidence of congenital long QT syndrome or known acquired QT interval prolongation (including QTcF > 450 in males or > 470 in females at screening).
• History of suicide attempt and/or suicidal ideation (of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS)) within 2 years of screening or subject is at risk of suicide at Screening or Baseline visits, in the opinion of the investigator.
• Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder which may include a positive drug screen at the Screening visit.
• Acute or chronic illness or history of illness, which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, any impairment of renal or hepatic function, poorly controlled diabetes, etc.
• Indication of impaired liver function (including values for AST, ALT, or bilirubin > 2 times the Upper Limit of Normal, unless isolated bilirubin > 2 x ULN due solely to Gilbert’s syndrome).
• Has a creatinine level > 2 x ULN.
• Anyone affiliated as a member of the investigative team or sponsor and/or anyone who may consent under duress.
• Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.