Clinical trial: A Study to Evaluate the Effects of ABX-1431 on Patients With Functional Dyspepsia (NCT02875678)

Eligibility criteria:
Inclusion Criteria:

          -  Patient has functional dyspepsia, postprandial distress syndrome (PDS) subtype,
             defined by the Rome III criteria.

          -  Patient has evidence of impaired gastric accommodation.

          -  Patient's Rome III Questionnaire results indicates that the intensity of co-existing
             epigastric pain and/or epigastric burning may be present, but have the same or lesser
             intensity than the evaluations of postprandial fullness or early satiety (i.e.
             epigastric pain and burning are not the prominent symptoms of the patient's functional
             dyspepsia).

          -  Patient recall of symptoms of gastrointestinal reflux over the past 8 weeks has no
             more than 2 episodes per week of heartburn or regurgitation.

          -  Patient is a male or female between 18 and 65 years of age at the pre-study/screening
             visit.

          -  Patient has a Body Mass Index (BMI) >18 to ≤30 kg/m2 at the pre-study/screening visit.

          -  Patient is judged to have no unmanaged significant disease or disorder based on
             medical history, physical examination, vital sign measurements, and laboratory safety
             obtained at pre-study/screening, and within 36 hours prior to first administration of
             study drug.

          -  Patient has no clinically significant abnormality of ECG performed at pre
             study/screening, and prior to first administration of study drug.

          -  Patient is willing to undergo the nutrient volume tolerance tests.

        Exclusion Criteria:

          -  Patient is under the age of legal consent.

          -  Female patients who are pregnant or breastfeeding.

          -  Patient has a personal history of a clinically significant psychiatric disorder
             (including severe affective disorder, anxiety disorder, post-traumatic stress
             disorder, psychotic disorder or drug-induced psychoses).

          -  Patient has a first-degree family history of schizophrenia, severe affective disorder,
             severe anxiety disorder, or other psychosis.

          -  Patient is taking antidepressants including SSRIs, SNRIs, tricyclic antidepressants,
             or atypical antidepressant medications such as bupropion, mirtazapine, trazodone or
             agomelatine. Patients taking these or other types of medicine for anxiety are also
             excluded. Patients who have discontinued antidepressants more than 6 months ago may be
             enrolled at the discretion of the Investigator. Patients who are taking gabapentin or
             pregabalin or buspirone are also excluded.

          -  Patient is mentally or legally incapacitated, has significant emotional problems at
             the time of pre-study/screening visit or is expected to have potential for mental
             incapacitation during the conduct of the study.

          -  Patient has had any gastrointestinal surgery. Those having undergone a simple
             appendectomy more than 1 year prior to the pre-study/screening visit may participate.

          -  Patient has had any acute gastrointestinal illness in the past 3 months.

          -  Patient has laboratory tests at screening or within 36 hours of first administration
             of study drug outside of these limits: Aspartate transaminase (AST) >1.5 x upper limit
             of normal (ULN) or Alanine transaminase (ALT) >1.5 x ULN.

          -  Patient has an estimated creatinine clearance (CrCl) of ≤80 mL/min based on the
             Cockcroft-Gault equation. An actual creatinine clearance, as measured using a 24-hour
             urine collection, may be used in place of, or in conjunction with the Cockcraft-Gault
             calculation. Patients with an actual or calculated creatinine clearance that is in the
             range of 72-79 mL/min (i.e., within 10% of 80 mL/min) may be enrolled in the study at
             the discretion of the Investigator.

          -  Patient has an active or prior history of neurological disorder, including but not
             limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive
             impairment, head trauma with prolonged loss of consciousness (>10 minutes), or
             migraine headaches.

          -  Patient has a history of clinically significant neoplastic disease, with the exception
             of adequately treated localized or in situ non-melanoma carcinoma of the skin (e.g.,
             basal cell carcinoma) or the cervix.

          -  Patient has a family history of long QT syndrome.

          -  Patient has a QTc interval of >450 msec (male patients) or >470 msec (female
             patients).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0