Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1101042 · 1 trial · 1 indication
Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
Maximum observed concentration of BAY1101042 in plasma after single dose administration
Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
| Arm | Type | Description |
|---|---|---|
| Subjects with mild renal impairment | EXPERIMENTAL | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Subjects with moderate renal impairment | EXPERIMENTAL | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Subjects with severe renal impairment | EXPERIMENTAL | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Matched healthy subject group | EXPERIMENTAL | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Name | Type | Description |
|---|---|---|
| BAY1101042 | DRUG | Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets) |
Inclusion Criteria: * Ability to understand and follow study-related instructions and ability to participate in the study for the entire period. * Age: 18 to 79 years (inclusive) at the screening visit. * Body mass index (BMI): 18 to 34 kg/m² (both inclusive). * Male or female subject. * Only women...
BAY1101042 is an investigational small molecule developed by Bayer AG for renal impairment. It is in Phase 1 clinical development in the nephrology therapeutic area. It has been studied in a single completed Phase 1 trial in Germany that enrolled 36 participants, including both men and women with renal impairment and healthy subjects.
BAY1101042 is being evaluated for renal impairment, a condition in which kidney function is reduced. The Phase 1 study assessed its pharmacokinetics, safety, tolerability and pharmacodynamic effects in people with renal impairment and in healthy subjects. It is investigational and has not been approved for any use.
BAY1101042 is developed by Bayer AG, the German pharmaceutical and life sciences company. Bayer's ordinary shares trade on the Frankfurt Stock Exchange, and its American Depositary Receipts trade over the counter in the United States under the ticker BAYRY.
BAY1101042 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a controlled Phase 1 trial conducted in Germany that enrolled 36 participants, including healthy volunteers and individuals with renal impairment.
BAY1101042 has been studied in one completed Phase 1 trial, NCT03235076. Titled a clinical study to evaluate the pharmacokinetics, safety, tolerability and pharmacodynamic effects of a single oral 10 mg BAY1101042 tablet dose, it enrolled 36 men and women with renal impairment and healthy subjects in Germany. The study is completed.