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BAY1817080- Formulation A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 - BAY1817080 Dose 1 | EXPERIMENTAL | Participants will receive one single oral dose of BAY1817080 - Formulation B at dose 1 under fasted condition |
| Group 2 - BAY1817080 Dose 2 | EXPERIMENTAL | Participants will receive a) one single oral dose of BAY1817080 - Formulation A at dose 2 with moderate-fat, moderate-calorie meal (MF, MC); b) one single oral dose of BAY1817080 - Formulation B at dose 2 along with one intravenous (i.v.) infusion of 0.1 mg \[13C715N\]-BAY1817080; and c) one single oral dose of BAY1817080 - Formulation B at dose 2 with high-fat, high-calorie meal (HF, HC). The 3 treatments will be administered with a randomized sequence |
| Group 3 - BAY1817080 Dose 3 | EXPERIMENTAL | Participants will receive a) one single oral dose of BAY1817080 - Formulation B at dose 3 under fasted condition; followed by one single oral dose of BAY1817080 - Formulation A at dose 3 with MF, MC; and followed by one single oral dose of BAY1817080 - Formulation B at dose 3 with HF, HC. The 3 treatments will be administered with a fixed sequence |
| Name | Type | Description |
|---|---|---|
| BAY1817080 - Formulation A | DRUG | Formulation A |
| BAY1817080 - Formulation B | DRUG | Formulation B |
| [13C715N]-BAY 181708 stable isotope label (SIL) | DRUG | 0.1 mg \[13C715N\]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B |
Inclusion criteria: * Healthy male subject * Age: 18 to 55 years (inclusive) at the time of informed consent and first dose of study medication * Body mass index (BMI) above/equal to 18 and below/equal to 30 kg/m\^2 at Screening * Body weight of at least 45 kg at Screening Exclusion criteria: * P...
BAY1817080 Formulation A is an investigational small molecule being studied for biological availability. A completed Phase 1 trial in healthy volunteers examined how quickly and to what extent the drug is taken up, distributed, broken down, and eliminated from the body, including differences between two tablet types and between oral and intravenous dosing.
BAY1817080 Formulation A is being developed by Bayer AG, which trades under the ticker BAYRY. The company sponsored a Phase 1 clinical trial of the drug in healthy volunteers in the Netherlands.
BAY1817080 Formulation A is in Phase 1 clinical development. It is an investigational drug, not yet approved, and the single Phase 1 trial listed for it has been completed. The study enrolled 30 healthy male volunteers aged 18 years and older.
BAY1817080 Formulation A has one completed clinical trial, NCT03773068. This Phase 1 study in the Netherlands evaluated how the drug is absorbed, distributed, metabolized, and excreted, comparing two tablet formulations and oral versus intravenous administration in 30 healthy male volunteers.
BAY1817080 Formulation A is a specific formulation of the investigational drug BAY1817080. The clinical trial NCT03773068 compared two different tablet types of BAY1817080, one of which is referred to as Formulation A, as well as oral dosing versus dosing in the vein.