Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Bayer AG. It is a tablet formulation of BAY1817080 that has been studied in healthy male volunteers to characterize how the body absorbs, distributes, breaks down and eliminates the compound, and to compare two tablet types against intravenous dosing.
BAY1817080 - Formulation A is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical work conducted with this formulation.
BAY1817080 - Formulation A is in Phase 1 development. It is investigational and has not been approved by the FDA. The single Phase 1 trial of this formulation has been completed, and no trials of it are currently active.
BAY1817080 - Formulation A has been evaluated in one Phase 1 trial, NCT03773068. That completed study enrolled 30 healthy male volunteers aged 18 years and older in the Netherlands and examined biological availability, comparing two tablet formulations and oral versus intravenous administration.
BAY1817080 - Formulation A is an alternative name for the same asset, BAY1817080 - Formulation A. Both names refer to the Bayer small molecule tablet formulation studied in the Phase 1 biological availability trial NCT03773068, so searches under either name point to the same investigational compound.
The Phase 1 trial NCT03773068 was a controlled, randomized study that was not double blinded. It enrolled 30 healthy male volunteers in the Netherlands and investigated how quickly and to what extent BAY1817080 is taken up, distributed, broken down and eliminated, plus differences between two tablet types and between oral and intravenous dosing.