A Phase 1 interventional study of bi-layer calcium carbonate tablet (BAY1180654) and Immediate release calcium carbonate tablet (BAY1180654) in Heartburn, Indigestion and Stomach Acid Related Symptoms, sponsored by Bayer. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Bayer · Phase 1, Interventional, and Other
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 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.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The night-time treatment sequence consists of two Treatment periods (Period 1 and Period 2) with each period consisting of a single dose of Investigational Medicinal Product (IMP). The two Treatment periods are separated by a least 6-8-day wash-out phase between IMP administration in Period 1 and 2.
Drug: bi-layer calcium carbonate tablet (BAY1180654) · Drug: Immediate release calcium carbonate tablet (BAY1180654)
The day-time treatment sequence consists of two Treatment periods (Period 1 and Period 2) with each period consisting of a single dose of IMP. The two Treatment periods are separated by a least 6-8-day wash-out phase between IMP administration in Period 1 and 2.
Drug: bi-layer calcium carbonate tablet (BAY1180654) · Drug: Immediate release calcium carbonate tablet (BAY1180654)
Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.
Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus.
Time frame: During night-time on Day 1
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus.
Time frame: During daytime on Day 1
Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator
Time frame: Up to 8 hours post-dose during night-time
Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator.
Time frame: Up to 6 hours post-dose during daytime
Change in mean gastric pH
Time frame: During night-time and daytime on Day 1
Gastrointestinal tract location using scintigraphic images.
Time frame: During night-time and daytime on Day 1
Initial radiolabel release time, using scintigraphic images
Time frame: During night-time and daytime on Day 1
Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images.
Time frame: During night-time and daytime on Day 1
Complete radiolabel release time, using scintigraphic images
Time frame: During night-time and daytime on Day 1
Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images.
Time frame: During night-time and daytime on Day 1
Participant questionnaire
The following questions will be asked: PERCEPTIONS Focusing on the sensory experience you have had from the tablet; please indicate how much you agree/disagree with each of the following statements? * This tablet feels like is easy to swallow * This tablet is pleasant to use
Time frame: On Day 1
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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