Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States
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|ClinicalTrials.gov Identifier: NCT01538797|
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : February 24, 2012
The objectives of the study were:
- To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect to their effects on basal- and food- stimulated gastric pH in healthy volunteers.
- To assess whether there is a relationship between the pharmacokinetics of YF476 and gastric pH in healthy volunteers.
- To assess the safety and tolerability of single doses of YF476 in healthy volunteers.
|Condition or disease||Intervention/treatment||Phase|
|Reflux Oesophagitis||Drug: YF476 Drug: Ranitidine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||YF476: Effects of a Single Dose at 3 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Ranitidine in Healthy Volunteers|
|Study Start Date :||July 1996|
|Actual Primary Completion Date :||August 1996|
|Actual Study Completion Date :||August 1996|
- Drug: YF476
There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100 mg), placebo and ranitidine 150 mg. There were at least 7 days between consecutive Treatment Days.
- Drug: Ranitidine
There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100mg), placebo and ranitidine 150mg. There were at least 7 days between consecutive Treatment Days.
- Clinically relevant changes from baseline in safety assessments [ Time Frame: 6 weeks ]Physical examination, ECG and safety tests of blood/urine at screening, 24h after dosing on each Treatment Day and at follow up. Blood pressure and heart rate before and at 0.5, 1, 2, 4, 6, 8, 12 and 24h after dosing on each Treatment Day.
- Numbers of adverse events [ Time Frame: 6 weeks ]Adverse events throughout the study
- Pharmacokinetic parameters: Cmax, Tmax, AUC 0-24 h, T1/2 [ Time Frame: 6 weeks ]Blood samples (8mL) before and at 0.5, 1, 2, 4, 6, 8, 12 and 24h after each dose for assay of YF476.
- Pharmacodynamic parameters: continuous 24 h ambulatory gastric pH [ Time Frame: 6 weeks ]Recording starts 0.5h before dosing on each Treatment Day; meals taken at 4, 9, 13 & 22h after dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538797
|Hammersmith Medicines Research|
|London, United Kingdom, NW10 7EW|
|Study Director:||Malcolm J Boyce, FRCP FFPM||Trio Medicines Limited|