Effects of YF476 and Rabeprazole on Gastric Function

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives are to find out in healthy subjects if:

• YF476 prevents the ECL-cell hyperplasia induced by repeated doses of rabeprazole - a proton pump inhibitor;

• YF476 also prevents rebound hyperacidity after stopping rabeprazole; and

• YF476 by itself causes neither ECL-cell hyperplasia after repeated doses nor rebound hyperacidity after stopping YF476.

The secondary objectives are to:

• assess the safety and tolerability of YF476, alone and in combination with rabeprazole;

• compare the effects of YF476, alone and in combination with rabeprazole, on serum gastrin and plasma CgA and SST;

• assess if there is a pharmacokinetic interaction between YF476 and rabeprazole;

• assess the pharmacokinetics of repeat doses of YF476 by itself; and

• study the metabolism of YF476.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trio Medicines Ltd.
• Treatments: Gastrins; Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• Men or women, deemed healthy on the basis of a clinical history, physical examination, ECG and safety tests of blood and urine;

• able to give fully-informed, written consent.

Exclusion Criteria:

• Women who are pregnant, lactating or using a steroid contraceptive.

• Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject.

• Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial 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.

• Evidence of high serum gastrin at screening or achlorhydria at baseline.

• Presence or history of severe adverse reaction to any drug.

• Use of a prescription medicine or antacids during the 28 days before the trial or use of an over-the-counter medication, with the exception of paracetamol, during the 7 days before the trial.

• Participation in a trial of a new drug substance or a prescription medicine within the previous 3 months.

• Presence or history of drug or alcohol abuse, or intake of more than 28 units of alcohol weekly (for men) or 21 units of alcohol weekly (for women).

• Blood pressure and heart rate in supine position at the screening examination outside the ranges 90-160 mm Hg systolic, 40-95 mm Hg diastolic; heart rate 40_100 beats/min.

• Possibility of the subject not co-operating with requirements of the protocol.

• Evidence of drug abuse on urine testing.

• Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.

• Loss of > 400 mL blood, e.g. blood donation, in the 3 months before the trial.

• Objection by the General Practitioner (GP) to the subject entering the trial.