Clinical trial NCT03065816: Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

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/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.

Primary outcomes:
measure: Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach
timeFrame: 4 hours after IMP administration
Secondary outcomes:
measure: Pharmacodynamics: AUC of meal percentage retention in the whole stomach
timeFrame: 4 hours after IMP administration
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Investigational site 826001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: