The objective of the study was to assess whether the tolerance to the effect of YF476 on
gastric pH observed with repeated doses in a previous study in healthy volunteers can be
avoided by using smaller doses of YF476.
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Full eligibility criteria for NCT01597674
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Males 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
A normal ECG at the screening examination.
A body mass index (Quetelet index) in the range 19.0-30.9:
*Body Mass Index = weight [kg]_ height [m]2
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.
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 and heart rate in seated position at the screening examination outside the ranges 90-150mmHg systolic, 40-90mmHg diastolic; heart rate 40-100 beats/min.
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.
All locations for NCT01597674
United Kingdom (1)
Hammersmith Medicines Research
London, United Kingdom
View full eligibility
Tris trial is registered with FDA with number: NCT01597674. The sponsor of the trial is Trio Medicines Ltd. and it is looking for 49 volunteers for the current phase.
Official trial title: A Double-blind, Placebo-controlled, Parallel-group Study of the Effect of 5, 10 and 25 mg Daily of YF476 for 14 Days on 24-hour Ambulatory Gastric pH and Plasma Gastrin Concentrations in Healthy Volunteers
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