Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers

NCT01597674 | Completed Phase 1

• 1 other identifier: 97-010
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reflux Oesophagitis

Keywords

YF476; gastrin receptor antagonist; gastric pH; gastrin; healthy subjects

Outcome Measures

Primary Outcomes (3)

• Pharmacodynamic parameters: gastric pH and plasma gastrin

  On Study Days 1, 7 and 14, ambulatory gastric pH recorded continuously from 0.5h before dosing until 24h after dosing. Subjects dosed between 0900-0930h. Standard meals and a drink (decaffeinated) taken at 4, 9, 13 and 22 h after dosing. Water (150mL) given at 2, 6, 8 and 11 h after dosing. On Study Days 1, 7 and 14, blood samples (4mL) taken via a cannula for assay of plasma gastrin at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 and 24 h after dosing.

  8 weeks

• Clinically relevant changes from baseline in safety assessments

  Physical examination, ECG and safety tests of blood/urine at screening and at follow up.

  8 weeks

• Numbers of adverse events

  Adverse events throughout study.

  8 weeks

Interventions

YF476 DRUG

There were 4 treatments: 3 dose levels of YF476 (5mg, 10mg, 25 mg) and placebo. Each treatment taken by mouth once daily for 14 days (Study Days 1-14). Each subject took 1 of the 4 treatments.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (Attachment 2).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trio Medicines Ltd.: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

YF 476

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Malcolm Boyce

  Trio Medicines Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: April 1, 1997
• Primary Completion: June 1, 1997
• Study Completion: June 1, 1997
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

GB (1)