Back to resultsPH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Z0063
Gaviscon
Sponsored by
About this trial
This is an interventional basic science trial for Gastroesophageal Reflux Disease
Eligibility Criteria
Inclusion criteria :
- Male or female subjects, between 18 and 55 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
- Subject has to accept a gastric probe.
Exclusion criteria:
- Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
- Blood donation, any volume, within 2 months before inclusion.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- Any subject in the exclusion period of a previous study according to applicable regulations.
- Any subject who cannot be contacted in case of emergency.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Positive result on urine drug screen.
- Positive alcohol breath test.
- Known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal.
- Any subject with difficulty in chewing and swallowing.
- Any subject with strong gag reflex.
- Any intake of aluminium and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 2500001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1 (Z0063 to Gaviscon)
Sequence 2 (Gaviscon to Z0063)
Arm Description
The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose
The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose
Outcomes
Primary Outcome Measures
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
Secondary Outcome Measures
Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose
4-hour median pH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03069963
Brief Title
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Official Title
A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
April 23, 2017 (Actual)
Study Completion Date
April 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
Detailed Description
The maximal total study duration per subject is 5 weeks and 1 day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1 (Z0063 to Gaviscon)
Arm Type
Experimental
Arm Description
The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose
Arm Title
Sequence 2 (Gaviscon to Z0063)
Arm Type
Experimental
Arm Description
The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose
Intervention Type
Drug
Intervention Name(s)
Z0063
Intervention Description
Pharmaceutical form: chewable tablets
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Gaviscon
Intervention Description
Pharmaceutical form: chewable tablets
Route of administration: oral
Primary Outcome Measure Information:
Title
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
Time Frame
4 hours after the investigational medicinal product (IMP) administration
Secondary Outcome Measure Information:
Title
Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose
Time Frame
4 hours after the IMP administration
Title
4-hour median pH
Time Frame
4 hours after the IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria :
Male or female subjects, between 18 and 55 years of age, inclusive.
Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive.
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
Subject has to accept a gastric probe.
Exclusion criteria:
Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
Blood donation, any volume, within 2 months before inclusion.
History or presence of drug or alcohol abuse.
Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
Any medication (including St John's Wort) within 14 days before inclusion, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
Any subject in the exclusion period of a previous study according to applicable regulations.
Any subject who cannot be contacted in case of emergency.
Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
Positive result on urine drug screen.
Positive alcohol breath test.
Known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal.
Any subject with difficulty in chewing and swallowing.
Any subject with strong gag reflex.
Any intake of aluminium and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 2500001
City
Gieres
ZIP/Postal Code
38610
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
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