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Reflux OesophagitisPhase 1NCT01538797

Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States

A Phase 1 study testing YF476 and Ranitidine in people with Reflux Oesophagitis, run by Trio Medicines Ltd. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of the study were: To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect to their effects on basal- and food- stimulated gastric pH in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Reflux Oesophagitis
What is being tested?
YF476 and Ranitidine
How many people
22 participants
Where
1 siteUnited Kingdom
Study dates
Jul 1996to Aug 1996
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female and 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Medicines Research

    London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: YF476: Effects of a Single Dose at 3 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Ranitidine in Healthy Volunteers

The objectives of the study were:

  • To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect to their effects on basal- and food- stimulated gastric pH in healthy volunteers.
  • To assess whether there is a relationship between the pharmacokinetics of YF476 and gastric pH in healthy volunteers.
  • To assess the safety and tolerability of single doses of YF476 in healthy volunteers.
Read the detailed description

YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and meal-stimulated gastric acid secretion and enhance gastric emptying of a liquid meal in man. Therefore YF476 might benefit patients with reflux oesophagitis. The compound has been well tolerated in animal toxicity studies at doses in excess of the projected therapeutic dose in patients, and merits studies in healthy volunteers. Extrapolation from data obtained in animals suggests that a single oral dose of about 10mg of YF476 should compare favourably with an oral dose of 150mg of ranitidine in man with respect to effect on basal and food-stimulated gastric acid secretion. Therefore in the proposed study a range of doses of YF476 encompassing that dose will be studied; the exact dose of YF476 will be chosen on the basis of the previous study but the top dose will not exceed 100mg. 24-hour ambulatory gastric pH will be monitored via an intragastric pH electrode (7-10). 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.

Being tested
YF476, Ranitidine
Keywords
YF476, gastrin receptor antagonist, gastric pH, healthy subjects, ranitidine
Medical subject headings
Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YF476Drug

    There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100 mg), placebo and ranitidine 150 mg. There were at least 7 days between consecutive Treatment Days.

  • RanitidineDrug

    There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100mg), placebo and ranitidine 150mg. There were at least 7 days between consecutive Treatment Days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically relevant changes from baseline in safety assessments

    Physical examination, ECG and safety tests of blood/urine at screening, 24h after dosing on each Treatment Day and at follow up. Blood pressure and heart rate before and at 0.5, 1, 2, 4, 6, 8, 12 and 24h after dosing on each Treatment Day.

    Measured: 6 weeks

  2. Numbers of adverse events

    Adverse events throughout the study

    Measured: 6 weeks

  3. Pharmacokinetic parameters: Cmax, Tmax, AUC 0-24 h, T1/2

    Blood samples (8mL) before and at 0.5, 1, 2, 4, 6, 8, 12 and 24h after each dose for assay of YF476.

    Measured: 6 weeks

  4. Pharmacodynamic parameters: continuous 24 h ambulatory gastric pH

    Recording starts 0.5h before dosing on each Treatment Day; meals taken at 4, 9, 13 \& 22h after dosing.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2012 (estimated)
  2. Study startJul 1996
  3. Primary completionAug 1996
  4. Study completionAug 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538797
Sponsor's protocol ID
96-016
Status last verified
Feb 2012
First submitted
15 Feb 2012
Last updated
24 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Boyce M, David O, Darwin K, Mitchell T, Johnston A, Warrington S. Single oral doses of netazepide (YF476), a gastrin receptor antagonist, cause dose-dependent, sustained increases in gastric pH compared with placebo and ranitidine in healthy subjects. Aliment Pharmacol Ther. 2012 Jul;36(2):181-9. doi: 10.1111/j.1365-2036.2012.05143.x. Epub 2012 May 20.

    PubMed 22607579

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YF476 and Ranitidine in people with Reflux Oesophagitis, run by Trio Medicines Ltd. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically relevant changes from baseline in safety assessments (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.

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