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

NCT03069963 | Completed Phase 1

• 3 other identifiers: PDY143622015-000763-13U1111-1183-5042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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

  4 hours after the investigational medicinal product (IMP) administration

Secondary Outcomes (2)

• 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 hours after the IMP administration

• 4-hour median pH

  4 hours after the IMP administration

Study Arms (2)

Sequence 1 (Z0063 to Gaviscon)

EXPERIMENTAL

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

Drug: Z0063; Drug: Gaviscon

Sequence 2 (Gaviscon to Z0063)

EXPERIMENTAL

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

Drug: Z0063; Drug: Gaviscon

Interventions

Z0063 DRUG

Pharmaceutical form: chewable tablets Route of administration: oral

Sequence 1 (Z0063 to Gaviscon); Sequence 2 (Gaviscon to Z0063)

Gaviscon DRUG

Pharmaceutical form: chewable tablets Route of administration: oral

Sequence 1 (Z0063 to Gaviscon); Sequence 2 (Gaviscon to Z0063)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 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.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 2500001

Gières, 38610, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: February 24, 2017
• Primary Completion: April 23, 2017
• Study Completion: April 23, 2017
• Last Updated: May 12, 2022

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)