- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01597674
Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
A Double-blind, Placebo-controlled, Parallel-group Study of the Effect of 5, 10 and 25 mg Daily of YF476 for 14 Days on 24-hour Ambulatory Gastric pH and Plasma Gastrin Concentrations in Healthy Volunteers
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Hammersmith Medicines Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic parameters: gastric pH and plasma gastrin
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
Physical examination, ECG and safety tests of blood/urine at screening and at follow up.
|
8 weeks
|
Numbers of adverse events
Time Frame: 8 weeks
|
Adverse events throughout study.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Malcolm Boyce, Trio Medicines Limited
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Reflux Oesophagitis
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
AstraZenecaCompletedGastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison SyndromeJapan
-
MEDA Pharma GmbH & Co. KGICON plc; Clinipace Worldwide; Trium Analysis Online GmbHTerminated
-
University of Kansas Medical CenterUniversity of Texas, Southwestern Medical Center at DallasRecruitingBarrett Oesophagitis With DysplasiaUnited States
-
Universitair Ziekenhuis BrusselUnknownAcid Reflux Esophagitis | Non-acid Reflux EsophagitisBelgium
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
University Hospital MuensterCompletedReflux, Gastroesophageal | Reflux Disease | Reflux, LaryngopharyngealGermany
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
Clinical Trials on YF476
-
Trio Medicines Ltd.Columbia University; University of CambridgeCompleted
-
Trio Medicines Ltd.Royal Liverpool University HospitalCompletedHypergastrinaemia | Chronic Atrophic Gastritis | Type I Gastric CarcinoidsUnited Kingdom
-
Trio Medicines Ltd.Norwegian University of Science and TechnologyTerminatedChronic Atrophic Gastritis | Hypergastrinemia | Type I Gastric CarcinoidsNorway
-
Trio Medicines Ltd.James Black FoundationCompleted
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
Trio Medicines Ltd.National Institutes of Health (NIH)TerminatedZollinger-Ellison Syndrome
-
Trio Medicines Ltd.James Black FoundationCompleted
-
Columbia UniversityTrio Medicines Ltd.CompletedBarrett's EsophagusUnited States, United Kingdom
-
Trio Medicines Ltd.CompletedDyspepsia | ECL-cell Hyperplasia | Parietal-cell Hyperplasia | Rebound Hyperacidity
-
Trio Medicines Ltd.Completed