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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT03065816
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
2.7
Actual Duration (Months)
12.6
Patients Per Site Per Month

Study Details

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
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
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 :
Feb 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 [4 hours after IMP administration]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Investigational site 826001 Merthyr Tydfil United Kingdom CF48 4dr

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT03065816
Other Study ID Numbers:
  • PDY14363
  • 2015-000764-34
  • U1111-1182-1864
First Posted:
Feb 28, 2017
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroesophageal Reflux
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination

Study Results

No Results Posted as of Apr 25, 2022