Type I gastric carcinoids, chronic atrophic gastritis and hypergastrinaemia. MedDRA version: 14.1 Level: PT Classification code 10060377 Term: Hypergastrinaemia System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10003685 Term: Atrophic gastritis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10017769 Term: Gastric carcinoid System Organ Class: 10029104 - Neoplasms benign,
Conditions
Interventions
Product Name: YF476
Product Code: YF476
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: YF476
CAS Number: 155488-25-8
Current Sponsor code: YF476
Other descriptive name: N/A
Concentration unit
Sponsors
Trio Medicines Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We include patients who meet the following criteria. *Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the out-patient clinic of the investigators; *Men, post-menopausal women, pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophrectomy, or pre-menopausal women using reliable contraception: condom and spermicide or intra-uterine device; *Adults = 18 years; *Good general health; and *Able to give fully-informed, written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: We exclude participants who meet the following criteria: *Women who are pregnant, lactating or using a steroid contraceptive; *History of gastric surgery, apart from surgery for gastric carcinoids; *Evidence of Zollinger-Ellison syndrome; *Prolonged QTc interval (>450 msec); *Certain medicines and herbal remedies taken during the 7 days before Visit 1 (see protocol); *Previous treatment with somatostatin; or *Participation in other clinical trials of unlicensed medicines within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out if YF476 is an effective medical treatment for type I gastric carcinoids. ;Secondary Objective: To find out if YF476 has any important side effects in patients with type I gastric carcinoids. To find out if YF476 affects biomarkers of ECL cell activity.;Primary end point(s): Visual assessment of the number, size and distribution of gastric carcinoids. ;Timepoint(s) of evaluation of this end point: Visual assessment of the number, size and distribution of gastric carcinoids is carried out at 6 and 12 weeks after starting the initial 12 weeks' treatment; and at 24 and 52 weeks after starting the extended dosing period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of YF476 on biomarkers. Safety and tolerability of long-term treatment with YF476.;Timepoint(s) of evaluation of this end point: Biomarker assessments after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period. Assessment of adverse events and safety tests of blood and urine after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period. | — |
Countries
United Kingdom
Contacts
Public ContactTrio Clinical Trial Info Desk
Trio Medicines Ltd
Outcome results
None listed