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Effect of Repeated Doses of YF476, Omeprazole and Placebo on Stomach Acidity in Healthy Volunteers

Information source: Trio Medicines Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Reflux Oesophagitis

Intervention: YF476 (Drug); Omeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Trio Medicines Ltd.

Official(s) and/or principal investigator(s):
Malcolm Boyce, Study Director, Affiliation: Trio Medicines Limited

Summary

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.

Clinical Details

Official title: YF476: Effects of Repeated Dosing at 2 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Omeprazole in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

Pharmacodynamic measurements: continuous 24h ambulatory gastric pH and 24 h plasma gastrin

Assessment of safety and tolerability

Pharmacokinetic analysis of plasma YF476 concentrations

Number of adverse events

Detailed description: YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and meal-stimulated gastric acid secretion, enhance gastric emptying of a liquid meal and increase lower oesphageal sphincter pressure in man. Therefore YF476 might benefit patients with reflux oesophagitis. YF476 has been well tolerated in healthy volunteers at single doses up to 100mg and remarkably well tolerated at repeat doses in animals up to 350 times the maximum dose planned for the proposed study. A range of doses of YF476 (25 and 100mg twice daily) will be administered to steady state. 24-hour ambulatory gastric pH will be monitored via an intragastric pH electrode to assess the effect of YF476 on basal and meal stimulated gastric pH. Although there is variability between subjects with respect to the effects of food and drug treatment on gastric pH, the methodology for measurement of ambulatory gastric pH is robust.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hammersmith Medicines Research, London, United Kingdom
Additional Information

Starting date: August 1996
Last updated: May 14, 2012

Page last updated: August 23, 2015

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