healthy adults and patients with acid-related diseases
Conditions
Interventions
investigational material(s)
Generic name etc : C13-CAC
INN of investigational material :
Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines)
Dosage an
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The investigator or subinvestigator shall conduct a screening test and select the subjects who meet the following criteria. 1) Patients with acid-related diseases who meet any of the followings and are judged to be in a stable condition by the investigator or subinvestigator, or healthy adults who meet any of the followings (1)patients with acid-related diseases (i) Patients with peptic ulcer (including those who are in the peptic ulcer scarring stage and whose clinical course is being monitored by a physician and those with a history of peptic ulcer and taking a PPI for prophylaxis against drug-induced ulcer) (ii) Patients with gastroesophageal reflux disease (GERD) by endoscopic diagnosis (including grade M according to the revised Los Angeles Classification) or by questionnaire for GERD (for example, scoring 8 or more points in the FSSG questionnaire) (2)Healthy adults Adults without a history of Helicobacter pylori infection who are judged medically healthy (without experience of Helicobacter pylori eradication therapy, and diagnosed to be negative to Helicobacter pylori infection by the serum antibody method, urine antibody method or urea breath test) 2) In/outpatient status: Not applicable 3) Subjects who are capable of practicing contraception until 28 days after final administration of the investigational medicinal product (IMP).
Exclusion criteria
Exclusion criteria: 1) Persons suspected to have hypothyroidism or hyperparathyroidism 2) Persons with hypercalcemia (serum calcium concentration: 11 mg/dL or more) 3) Persons with a history of upper gastrointestinal surgery (excluding endoscopic mucosal resection and endoscopic submucosal dissection) 4) Persons who have a constriction in the nasal cavity, pharyngeal region or esophageal lumen and in whom 24-hour gastric pH monitoring is expected to be difficult. 5) Persons with hypersensitivity to drugs (including all prescription drugs and over-the-counter [OTC] drugs) (including previous history) 6) Persons who have taken an investigational product in another clinical trial within 30 days prior to IMP administration. 7) Persons from whom a total of blood volume exceeding 200 mL has been collected within 30 days prior to IMP administration or exceeding 400 mL within 90 days (such as for blood donation). 8) Lactating women, pregnant women or women suspected to be pregnant. 9) Other persons judged to be inappropriate by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 13CO2 concentration in expired air 13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air 24-hour gastric pH Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration | — |
Outcome results
None listed