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Also known as bi-layer calcium carbonate tablet (BAY1180654)
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 antacid tablet being studied for heartburn and other stomach acid related symptoms, including indigestion and nocturnal acid symptoms. It is a small molecule developed by Bayer AG under the code BAY1180654. It has been tested in a Phase 1 first-in-human study in healthy male volunteers.
Bi-layer calcium carbonate is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. The drug candidate is also identified by the code BAY1180654. Bayer conducted the first-in-human study of the tablet in the United Kingdom.
Bi-layer calcium carbonate is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved for any indication. The completed study enrolled 21 healthy male participants aged 18 years and older.
Bi-layer calcium carbonate has been evaluated in one completed Phase 1 trial, NCT06293326. The first-in-human study compared a bi-layer calcium carbonate antacid tablet with a standard, non-layered calcium carbonate tablet in 21 healthy male participants in the United Kingdom. The study was randomized and controlled.
Yes, bi-layer calcium carbonate is also known as bi-layer calcium carbonate tablet (BAY1180654). BAY1180654 is the Bayer development code for the same investigational antacid tablet. Both names refer to the small molecule being studied for heartburn and stomach acid related symptoms.