Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01601418
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2012-05-15
Brief Title:
Effect of Single Doses of YF476 on Stomach Acidity
Sponsor:
Trio Medicines Ltd
Organization:
Trio Medicines Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 01 and 10 mgkg 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 06 microgramskghour is a submaximal and well-tolerated dose
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 01 and 10 mgkg 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 06 microgramskghour is a submaximal and well-tolerated dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None