HypergastrinaemiaPhase 1NCT01601418
Effect of Single Doses of YF476 on Stomach Acidity
A Phase 1 study testing YF476 in people with Hypergastrinaemia, run by Trio Medicines Ltd. at 1 site in United Kingdom.
Trial summary
The objective of the study was to assess the effect of a range of single oral doses of YF476 on pentagastrin-induced gastric acid output 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
- Hypergastrinaemia
- What is being tested?
- YF476
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2001to Jan 2002
- 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
- Healthy male or female volunteers.
- Aged 18-45 years.
- A body mass index (Quetelet index) in the range 18.0-30.9.
- Women at risk of pregnancy must use a reliable method of contraception.
- 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 volunteer's participation hazardous.
- No clinically relevant abnormal laboratory values at the screening evaluation, including a normal ECG.
- Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study.
- Willingness to give written consent to participate after reading the Consent Form, and after having the opportunity to discuss the study with an investigator or his deputy.
Who cannot join
- Women who are pregnant or lactating.
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the study or make it unnecessarily hazardous.
- Positive test for Helicobacter pylori.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
- Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
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- Use of a prescription medicine (except oral contraceptives in females) during the 30 days before the study or use of an over-the-counter medication, with the exception of paracetamol, during the 7 days before the study.
- Participation in other clinical studies of a new chemical entity or a prescription medicine within the previous 3 months.
- Smokers.
- 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 seated 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 that the volunteer will not cooperate with the requirements of the protocol.
- Evidence of drug abuse on urine testing.
- Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.
- Loss of more than 400 mL blood during the 3 months before the study, e.g. as a blood donor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Single-dose, 5-way Crossover Study of the Effect of YF476 (1, 5, 25 & 100 mg) on Pentagastrin-induced Gastric Acid Output in Healthy Volunteers
The objective of the study was to assess the effect of a range of single oral doses of YF476 on pentagastrin-induced gastric acid output in healthy volunteers
Read the detailed description
The rationale for the study was as follows.
On the basis of the pre-clinical studies, the original target disease for YF476 was gastro-oesophageal reflux disease (GORD), not only because of the excellent anti-secretory activity of YF476 but also because of its potential for increasing gastric emptying. But loss of the anti-secretory effect of YF476 in healthy subjects after repeated dosing excludes its use as an anti-secretory agent in patients with GORD. However, there is some evidence from within our repeated-dose studies in healthy subjects that gastrin receptors are blocked despite loss of the anti-secretory activity of YF476. Further evidence that repeated doses of YF476 cause sustained blockade of gastrin receptors comes from several types of study in animals. First, in the 13-week toxicology studies, all dose levels of YF476 reduced the ECL population, unlike other anti-secretory agents, histamine H2-antagonists and proton-pump inhibitors, which increase the ECL population. Second, YF476 at doses of 0.1 and 1.0 mg/kg subcutaneously twice daily for 14 days in rats abolished the increase in gastric output induced by pentagastrin on Days 1, 7 and 14.
This protocol describes a study in healthy subjects using inhibition of pentagastrin-induced gastric acid output as a surrogate marker of efficacy of YF476. Pentagastrin has been used for many years to test gastric function in healthy subjects and patients. Intravenous infusion of 0.6 micrograms/kg/hour is a submaximal and well-tolerated dose.
- Conditions
- Hypergastrinaemia
- Being tested
- YF476, Placebo
- Keywords
- YF476, gastrin receptor antagonist, pentagastrin, gastric acid, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YF476Drug
Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.
PlaceboDrug
Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of YF476
Assessed by medical examinations, ECG, safety tests of blood and urine
Measured: 12 weeks
Tolerability of YF476
Assessed by adverse events
Measured: 12 weeks
Efficacy of YF476
Comparison of YF476 doses and placebo with respect to:
- area under the total H+ secretion, i.e. [H+] x volume-time curve (corrected for basal secretion)
- peak total H+ secretion, i.e. [H+] x volume-secretory rate (corrected for basal secretory rate)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startOct 2001
- Primary completionJan 2002
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypergastrinaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trio Medicines Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- James Black Foundation
- Responsible party
- Sponsor
- Investigators
- Malcolm Boyce, Study director, Trio Medicines Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601418
- Sponsor's protocol ID
- 01-022
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Single-dose, 5-way Crossover Study of the Effect of YF476 (1, 5, 25 & 100 mg) on Pentagastrin-induced Gastric Acid Output in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01601418
- Acronym / sponsor ID
- 01-022
- Conditions
- Hypergastrinaemia
- Keywords
- YF476, gastrin receptor antagonist, pentagastrin, gastric acid, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Trio Medicines Ltd.Industry (pharma, biotech, devices)
- Collaborators
- James Black Foundation
- Study start
- Oct 2001
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to assess the effect of a range of single oral doses of YF476 on pentagastrin-induced gastric acid output in healthy volunteers
Detailed description
The rationale for the study was as follows.
On the basis of the pre-clinical studies, the original target disease for YF476 was gastro-oesophageal reflux disease (GORD), not only because of the excellent anti-secretory activity of YF476 but also because of its potential for increasing gastric emptying. But loss of the anti-secretory effect of YF476 in healthy subjects after repeated dosing excludes its use as an anti-secretory agent in patients with GORD. However, there is some evidence from within our repeated-dose studies in healthy subjects that gastrin receptors are blocked despite loss of the anti-secretory activity of YF476. Further evidence that repeated doses of YF476 cause sustained blockade of gastrin receptors comes from several types of study in animals. First, in the 13-week toxicology studies, all dose levels of YF476 reduced the ECL population, unlike other anti-secretory agents, histamine H2-antagonists and proton-pump inhibitors, which increase the ECL population. Second, YF476 at doses of 0.1 and 1.0 mg/kg subcutaneously twice daily for 14 days in rats abolished the increase in gastric output induced by pentagastrin on Days 1, 7 and 14.
This protocol describes a study in healthy subjects using inhibition of pentagastrin-induced gastric acid output as a surrogate marker of efficacy of YF476. Pentagastrin has been used for many years to test gastric function in healthy subjects and patients. Intravenous infusion of 0.6 micrograms/kg/hour is a submaximal and well-tolerated dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female volunteers.
- Aged 18-45 years.
- A body mass index (Quetelet index) in the range 18.0-30.9.
- Women at risk of pregnancy must use a reliable method of contraception.
- 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 volunteer's participation hazardous.
Key exclusion criteria (15 listed)
- Women who are pregnant or lactating.
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the study or make it unnecessarily hazardous.
- Positive test for Helicobacter pylori.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YF476Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL. | Drug | – |
| PlaceboEach subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL. | Drug | – |
Primary outcome
Safety of YF476
Time frame: 12 weeks
Assessed by medical examinations, ECG, safety tests of blood and urine
Tolerability of YF476
Time frame: 12 weeks
Assessed by adverse events
Efficacy of YF476
Time frame: 12 weeks
Comparison of YF476 doses and placebo with respect to: 1. area under the total H+ secretion, i.e. [H+] x volume-time curve (corrected for basal secretion) 2. peak total H+ secretion, i.e. [H+] x volume-secretory rate (corrected for basal secretory rate)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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Autoimmune Gastritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Boyce study director
Trio Medicines Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YF476 in people with Hypergastrinaemia, 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 8 inclusion and 15 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 18 May 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?
Safety of YF476 (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2012.