The objectives of this study were:
To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
their effect on basal- and food- stimulated gastric pH in healthy volunteers.
To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
their effect on basal and meal stimulated pH.
To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in
healthy volunteers.
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Inclusion Criteria:
- Male or female aged 18-45 years.
- No clinically relevant abnormal findings in the clinical history or physical
examination at the screening assessment which could interfere with the objectives of
the study or make the subject's participation hazardous.
- No clinically relevant abnormal laboratory values at the screening evaluation
(Attachment 2).
- A normal ECG at the screening examination.
- A body mass index (Quetelet index) in the range 19-30:
Body Mass Index = weight [kg]_ height [m]2
- Normal blood pressure and heart rate at the screening examination, i. e. BP 90-150mmHg
systolic, 40-95mmHg diastolic; heart rate 40-100 beats/min in seated position.
- Subjects must be of sufficient intelligence to understand the nature of the study and
any hazards of their participation in it. They must be able to communicate
satisfactorily with the Investigator and to participate in, and comply with the
requirements of, the entire study.
- Subjects must give their written consent to participate after reading the
Information-for-Volunteers Leaflet and Consent Form, and after having the opportunity
to discuss the study with the Investigator or his deputy.
Exclusion Criteria:
- Females who are pregnant or lactating, or who are sexually active and are not using a
reliable method of contraception.
- Clinically relevant abnormal history or physical findings at the screening
assessment, which could interfere with the objectives of the study or the safety of
the subject's participation.
- Clinically relevant abnormalities of laboratory values or ECG at screening
evaluation.
- Presence of acute or chronic illness or history of chronic illness sufficient to
invalidate subject's participation in the study or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes
mellitus, coronary heart disease or history of any psychotic mental illness.
- Participation in other clinical studies of a new chemical entity or a prescription
medicine within the previous 3 months.
- Presence or history of drug or alcohol abuse, or intake of more than 40 units of
alcohol weekly.
- Loss of more than 400mL blood during the 3 months before the study, e. g. as a blood
donor.
- Use of prescription medication during 30 days before the study.
- Use of an over-the-counter medicine during 7 days before the study
- Blood pressure or heart rate outside those values specified under inclusion criterion
(f).
- Possibility that the subject will not cooperate with the requirements of the
protocol.
- Evidence of drug abuse on urine testing at study entry.
- Positive test for hepatitis B or C or HIV 1 & 2.
- High risk of hepatitis or HIV infection.
- History of severe allergic disease.