Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bi-layer calcium carbonate · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * 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 (li...
Bi-layer calcium carbonate is an investigational small molecule being developed for heartburn and related stomach acid symptoms, including indigestion and nocturnal stomach acid related symptoms. It is a bi-layer antacid tablet designed to be compared against a standard, non-layered calcium carbonate tablet.
Bi-layer calcium carbonate is being developed by Bayer AG, which trades under the ticker BAYRY. The drug is currently in early clinical development for gastrointestinal conditions such as heartburn.
Bi-layer calcium carbonate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under evaluation.
Bi-layer calcium carbonate has one completed Phase 1 trial, NCT06293326, a first-in-human study in healthy male participants. The trial compared the bi-layer tablet to a standard calcium carbonate tablet for heartburn and related symptoms. It enrolled 21 participants in the United Kingdom.
Bi-layer calcium carbonate is a distinct formulation of calcium carbonate, featuring a bi-layer tablet structure. It is being studied to see how well it works compared to a standard, non-layered calcium carbonate tablet for heartburn and stomach acid related symptoms.