Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects

• ClinicalTrials.gov Identifier: NCT03065816
• Recruitment Status: Completed
• First Posted: February 28, 2017
• Last Update Posted: April 25, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

Primary Objective:

Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.

Secondary Objective:

Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in healthy adult subjects.

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Disease	Drug: Z0063; Drug: Gaviscon	Phase 1

Detailed Description:

The total study duration per subject is 37 days including a screening period up to 21 days, a wash-out period of 4-7 days and a follow-up of 4-7 days.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Open-label, 2-Treatment Crossover Study to Compare by Scintigraphy, the Antireflux 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 Subjects
• Actual Study Start Date: February 9, 2017
• Actual Primary Completion Date: May 2, 2017
• Actual Study Completion Date: May 2, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sequence 1 (Z0063 to Gaviscon); The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose	Drug: Z0063; Pharmaceutical form: chewable tablets Route of administration: oral; Drug: Gaviscon; Pharmaceutical form: chewable tablets Route of administration: oral
Experimental: Sequence 2 (Gaviscon to Z0063); The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose	Drug: Z0063; Pharmaceutical form: chewable tablets Route of administration: oral; Drug: Gaviscon; Pharmaceutical form: chewable tablets Route of administration: oral

Outcome Measures

Primary Outcome Measures :

1. Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach [ Time Frame: 4 hours after IMP administration ]

Secondary Outcome Measures :

1. Pharmacodynamics: AUC of meal percentage retention in the whole stomach [ Time Frame: 4 hours after IMP administration ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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/m^2, inclusive.
• Certified as healthy by a comprehensive clinical assessment.
• Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
• Subject has to be willing to eat the standard radiolabelled meal (eggs on toasts and orange juice).

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 of more than 450 mL within 3 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 subject in the exclusion period of a previous study: participation in a new chemical entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.
• 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 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/or swallowing.
• Participation in a study in which radioisotopes were administered or in which subject was exposed to any radiation other than normal background radiation within the 12 months before the screening visit.
• Any intake of aluminum 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.

Contacts and Locations

Locations

United Kingdom

Investigational site 826001

Merthyr Tydfil, United Kingdom, CF48 4dr

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03065816
• Other Study ID Numbers: PDY14363; 2015-000764-34 ( EudraCT Number ); U1111-1182-1864 ( Other Identifier: UTN )
• First Posted: February 28, 2017
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents