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BAY2927088 coated

Phase 1

Advanced Non-small Cell Lung Cancer | Small molecule | Oncology |Bayer AG|Last Updated: Jun 28, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

BAY2927088 coated · 1 trial · 4 indications

Phase 1 1
NCT06221475A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male ParticipantsAdvanced Non-small Cell Lung Cancer
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants
Advanced Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

For Part 1: Absolute bioavailability (F) as percent F (%F) after oral administration as oral to IV ratio of AUC/D (Area under the concentration curve per dose)
Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: AUC of BAY2927088 and [14C]-BAY2927088
Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: AUC/D of BAY2927088 and [14C]-BAY2927088
Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: Cmax (maximum concentration) of BAY2927088 and [14C]-BAY2927088
Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: Cmax/D of BAY2927088 and [14C]-BAY2927088
Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 2: Amount of BAY2927088 and its metabolites excreted in urine (%AEur), in feces (%AEfec), and in vomit as a percent of the dose (%AEvom, if applicable)
Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

Based on radioactivity excreted in urine and feces, and vomit as a percentage of the dose to assess mass balance of total radioactivity

For Part 2: AUC of total radioactivity in plasma and whole blood. (AUC(0-tlast) will be used as primary parameter if mean AUC(tlast-∞) >20% of AUC)
Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: Cmax of total radioactivity in plasma and whole blood
Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: AUC of BAY2927088 in plasma. (AUC[0-tlast] will be used as primary parameter if mean AUC[tlast-∞] >20% of AUC)
Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: Cmax of BAY2927088 in plasma
Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

Secondary Endpoints

Number of participants with treatment-emergent adverse events (TEAE) and severity of treatment-emergent adverse events
From dosing up to 15 days after last dosing
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Healthy male participants from NetherlandsEXPERIMENTALIn Part 1, participants will receive a single dose of 40 mg of BAY2927088 as oral tablets on Study Day 1 approximately 30 min after a light meal, they will then receive a single dose of a microtracer not exceeding 100 ug of \[14C\]-BAY2927088 and 37 kilo becquerel (kBq) \[1000 nano Curie (nCi)\] of 14C will be administered intravenously (IV) as a 15 min infusion ending at the expected median time to maximum concentration (tmax) for the tablet (2 hours oral post-dose). After 2 days of washout, participants will move on to Part 2. In Part 2, on Study Day 1 approximately 30 min after a light meal, all enrolled participants will receive a single dose of 40 mg BAY2927088 containing approximately 3.7 MBq (100 µCi) \[14C\]-BAY 2927088 administered as an oral solution

Interventions

NameTypeDescription
BAY2927088 coated tablet 10 mgDRUG4 coated tablets (10 mg) per single dose 30 min after a light meal
[14C]-BAY2927088 solution for infusionDRUGIV infusion 15 min ending at 2 hours oral post-dose
[14C]-BAY2927088 oral solutionDRUGAfter a light meal
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Capable of giving signed informed consent * Participant must be 18 or age of legal maturity to 55 years of age inclusive, at the time of signing the informed consent * Participants who are overtly healthy as determined by the investigator or medically qualified designee based ...

Countries:Netherlands
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Advanced Non-small Cell Lung Cancer")

Frequently asked questions about BAY2927088 coated

What is BAY2927088 used for?

BAY2927088 is an investigational small molecule being developed for advanced non-small cell lung cancer. It is currently in Phase 1 clinical development. The drug is being studied in healthy male participants to understand how it is taken up and handled by the body.

Who makes BAY2927088?

BAY2927088 is being developed by Bayer AG, a pharmaceutical company. Bayer's stock is traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for advanced non-small cell lung cancer.

What phase is BAY2927088 in?

BAY2927088 is in Phase 1 clinical development. A Phase 1 study has been completed that evaluated how the drug is taken up and handled by the body in healthy male participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BAY2927088 in?

BAY2927088 has one completed clinical trial, NCT06221475, which was a Phase 1 study in healthy male participants. The study enrolled 8 participants and was conducted in the Netherlands. It was an uncontrolled, open-label study that examined how the drug is absorbed and processed by the body.

Is BAY2927088 the same as BAY2927088 coated?

Yes, BAY2927088 coated refers to the same drug as BAY2927088. The term 'coated' likely describes a specific formulation of the drug. The drug is being developed by Bayer AG for advanced non-small cell lung cancer and is currently in Phase 1 clinical development.