Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1101042 · 2 trials · 2 indications
Assessment of treatment emergent adverse events from first study drug intake until follow up
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 |
|---|---|---|
| Single/multiple doses of 10 mg BAY1101042 or placebo | EXPERIMENTAL | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 20 mg BAY1101042 or placebo | EXPERIMENTAL | Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 30 mg BAY1101042 or placebo | EXPERIMENTAL | Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 40 mg BAY1101042 or placebo | EXPERIMENTAL | Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 50 mg BAY1101042 or placebo | EXPERIMENTAL | Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo | EXPERIMENTAL | Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days |
| 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, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Placebo | DRUG | Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d) |
Inclusion Criteria: * The informed consent must be signed before any study specific tests or procedures are done. * Healthy male subject. * Age: 18 to 45 years (inclusive) at the screening. * Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2. * Ability to understand and follow study-...
BAY1101042 is an investigational small molecule being developed by Bayer AG for use in renal impairment and healthy volunteer studies. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics, safety, tolerability, and pharmacodynamic effects.
BAY1101042 is being studied for use in renal impairment and in healthy volunteers. Clinical trials are evaluating its pharmacokinetics, safety, tolerability, and pharmacodynamic effects following oral tablet doses.
BAY1101042 is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development.
BAY1101042 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with renal impairment and one in healthy male subjects. The drug is investigational and not yet approved.
BAY1101042 has two completed Phase 1 trials. NCT03235076 evaluated a single 10 mg oral dose in men and women with renal impairment and healthy subjects. NCT03252002 evaluated single and multiple oral doses in healthy male subjects. Both trials were conducted in Germany.
BAY1101042 is the only name provided for this investigational drug. No alternative names have been reported in the clinical trial information.