HeartburnPhase 1NCT06293326
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
A Phase 1 study testing bi-layer calcium carbonate tablet (BAY1180654) and Immediate release calcium carbonate tablet (BAY1180654) in people with Heartburn and Indigestion, run by Bayer at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heartburn, Indigestion, Stomach Acid Related Symptoms
- What is being tested?
- bi-layer calcium carbonate tablet (BAY1180654) and Immediate release calcium carbonate tablet (BAY1180654)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2024to 15 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Participant must be 18 to ≤65 years of age inclusive, at the time of signing the informed consent.
- Participants must have a verified diagnosis of "healthy": the results of the standard clinical, laboratory, and instrumental examinations are within the normal range (limits of reference range). The Investigator can interpret individual findings based on the participant's age, physical state and level of fitness. Participants with readings marginally outside the normal range may be included in the study if, in the Investigator's opinion, these are not clinically significant (NCS); this decision will be documented in the Case Report Form (CRF).
- Results of safety laboratory tests are within normal range (limits of reference range).
- Non-smokers or passive smokers exposed to smoke in an enclosed room for less than 4 h per week.
- Body mass index (BMI) within the range 18.5 to ≤30 kg/m2 (inclusive).
Show all 9Show fewer
- Unless participant has had bilateral orchidectomy or a vasectomy (with confirmed sterility), must be abstinent from penile-vaginal intercourse for the duration of the study and agree to remain abstinent for 90 days after the last dose of IMP, OR agree to use a condom during each episode of penile-vaginal intercourse, in addition to their partner (if a person who could become pregnant) using a highly effective form of contraception as described in protocol.
- Participant has given written informed consent to participate in the trial prior to admission to the trial as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol.
Who cannot join
- A history of physical or psychiatric diseases (e.g., diabetes, hypothyroidism and other metabolic diseases, renal disease).
- Recent unexplained significant weight loss (6-7 kg) in the last 6 months.
- A history or current symptoms of Zollinger-Ellison syndrome, gastric carcinoma, peptic ulcer disease, pernicious anaemia, Barrett's oesophagus or systemic sclerosis.
- Meal-induced heartburn of severe severity, historically and -
- Use of any H2-receptor antagonist and/or PPI within one week prior to Screening.
- History and currently prescribed medication for treatment of heartburn associated with increased acidity, reflux esophagitis, and peptic ulcers.
- Current or history of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Center, Randomized, Two-way Crossover Parallel Group, Trial to Assess the Mechanism of Action of a Bi-layer Swallowable Tablet (Immediate Release and Sustained Release) Containing Calcium Carbonate Antacid in an Overnight and Day Application as Compared With a Standard, Non-layered (Immediate Release) Calcium Carbonate Swallow Tablet in Fed Healthy Male Participants.
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).
Read more
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:
- visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
- 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
- Being tested
- bi-layer calcium carbonate tablet (BAY1180654), Immediate release calcium carbonate tablet (BAY1180654)
- Medical subject headings
- Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bi-layer calcium carbonate tablet (BAY1180654)Drug
Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.
Immediate release calcium carbonate tablet (BAY1180654)Drug
Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing.
| Study group | Role | What they receive |
|---|---|---|
| Night-time sequence | Experimental | 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. Receives: Drug: bi-layer calcium carbonate tablet (BAY1180654); Drug: Immediate release calcium carbonate tablet (BAY1180654) |
| Day-time sequence | Experimental | 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. Receives: Drug: bi-layer calcium carbonate tablet (BAY1180654); Drug: Immediate release calcium carbonate tablet (BAY1180654) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus.
Measured: During night-time on Day 1
Secondary outcomes (10)
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus.
Measured: 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
Measured: 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.
Measured: Up to 6 hours post-dose during daytime
Change in mean gastric pH
Measured: During night-time and daytime on Day 1
Gastrointestinal tract location using scintigraphic images.
Measured: During night-time and daytime on Day 1
Initial radiolabel release time, using scintigraphic images
Measured: During night-time and daytime on Day 1
Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images.
Measured: During night-time and daytime on Day 1
Complete radiolabel release time, using scintigraphic images
Measured: 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.
Measured: 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
Measured: On Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start6 Mar 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293326
- Sponsor's protocol ID
- 22553
- Status last verified
- Jul 2024
- First submitted
- 16 Feb 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Center, Randomized, Two-way Crossover Parallel Group, Trial to Assess the Mechanism of Action of a Bi-layer Swallowable Tablet (Immediate Release and Sustained Release) Containing Calcium Carbonate Antacid in an Overnight and Day Application as Compared With a Standard, Non-layered (Immediate Release) Calcium Carbonate Swallow Tablet in Fed Healthy Male Participants.
- ClinicalTrials.gov ID
- NCT06293326
- Acronym / sponsor ID
- 22553
- Conditions
- Heartburn, Indigestion, Stomach Acid Related Symptoms, Nocturnal Stomach Acid Related Symptoms, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night-time sequence | Experimental | Drug: bi-layer calcium carbonate tablet (BAY1180654), Drug: Immediate release calcium carbonate tablet (BAY1180654)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. |
| Day-time sequence | Experimental | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male
- Participant must be 18 to ≤65 years of age inclusive, at the time of signing the informed consent.
- Participants must have a verified diagnosis of "healthy": the results of the standard clinical, laboratory, and instrumental examinations are within the normal range (limits of reference range). The Investigator can interpret individual findings based on the participant's age, physical state and level of fitness. Participants with readings marginally outside the normal range may be included in the study if, in the Investigator's opinion, these are not clinically significant (NCS); this decision will be documented in the Case Report Form (CRF).
- Results of safety laboratory tests are within normal range (limits of reference range).
- Non-smokers or passive smokers exposed to smoke in an enclosed room for less than 4 h per week.
Key exclusion criteria (7 listed)
- A history of physical or psychiatric diseases (e.g., diabetes, hypothyroidism and other metabolic diseases, renal disease).
- Recent unexplained significant weight loss (6-7 kg) in the last 6 months.
- A history or current symptoms of Zollinger-Ellison syndrome, gastric carcinoma, peptic ulcer disease, pernicious anaemia, Barrett's oesophagus or systemic sclerosis.
- Meal-induced heartburn of severe severity, historically and -
- Use of any H2-receptor antagonist and/or PPI within one week prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bi-layer calcium carbonate tablet (BAY1180654)Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing. | Drug | Day-time sequence, Night-time sequence |
| Immediate release calcium carbonate tablet (BAY1180654)Singal dose; two tablets; administered 1-2 hours post standardized meal depending on day or night dosing. | Drug | Day-time sequence, Night-time sequence |
Primary outcome
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus.
Time frame: During night-time on Day 1
10 secondary outcomes
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
Time frame: On Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bi-layer calcium carbonate tablet (BAY1180654) and Immediate release calcium carbonate tablet (BAY1180654) in people with Heartburn and Indigestion, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. (time frame: During night-time on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.