MedTrace Logo

A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants

NCT06293326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-07-03

No results posted yet for this study

Summary

Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).

Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).

In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.

The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.

For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.

The participants will be randomly (by chance) assigned to one of two treatment groups:

Participants in the first group will take the treatments at night.

Participants in the second group will take the treatments during the day.

All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.

Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:

1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
2. visits for treatment with a gap of 6-8 days between each treatment, and

1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.

During the study, the doctors and their study team will:

check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)

take images of the stomach at different times after taking the treatment

measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach

ask the participants questions about how easy it is to take the study treatment

ask the participants what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.

As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned.

Conditions

  • Heartburn
  • Indigestion
  • Stomach Acid Related Symptoms
  • Nocturnal Stomach Acid Related Symptoms
  • Healthy Volunteers

Interventions

DRUG

bi-layer calcium carbonate tablet (BAY1180654)

Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.

DRUG

Immediate release calcium carbonate tablet (BAY1180654)

Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2024-05-15
Completion
2024-05-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06293326 on ClinicalTrials.gov