Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||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|
- Pharmacodynamic parameters: gastric pH and plasma gastrin [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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.
- Clinically relevant changes from baseline in safety assessments [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Physical examination, ECG and safety tests of blood/urine at screening and at follow up.
- Numbers of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Adverse events throughout study.
|Study Start Date:||April 1997|
|Study Completion Date:||June 1997|
|Primary Completion Date:||June 1997 (Final data collection date for primary outcome measure)|
There were 4 treatments: 3 dose levels of YF476 (5mg, 10mg, 25 mg) and placebo.
Each treatment taken by mouth once daily for 14 days (Study Days 1-14). Each subject took 1 of the 4 treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597674
|Hammersmith Medicines Research|
|London, United Kingdom|
|Study Director:||Malcolm Boyce||Trio Medicines Limited|