PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects

Sanofi

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Gaviscon; Drug: Z0063

Study type: Interventional

Funder types: Industry

Identifiers

NCT03069963

PDY14362

U1111-1183-5042 (Other Identifier)

2015-000763-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The maximal total study duration per subject is 5 weeks and 1 day.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Sequence 1 (Z0063 to Gaviscon)

Experimental group

Description:

The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose

Treatment:

Drug: Gaviscon

Drug: Z0063

Sequence 2 (Gaviscon to Z0063)

Experimental group

Description:

The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose

Treatment:

Drug: Gaviscon

Drug: Z0063