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BAY1834845

Phase 1

Healthy Volunteers | Small molecule | Dermatology |Bayer AG|Last Updated: Dec 16, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

BAY1834845 · 4 trials · 5 indications

Phase 1 4
NCT05003089A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male ParticipantsImmune Mediated Inflammatory Diseases
COMPLETED51 Analytics
NCT03493269A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With PsoriasisHealthy Volunteers
COMPLETED72 Analytics
NCT03244462Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With MethotrexateInflammation
COMPLETED10 Analytics
NCT03054402First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845Pelvic Inflammatory Disease
COMPLETED70 Analytics
PHASE1COMPLETED
A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male Participants
Immune Mediated Inflammatory Diseases
NCT0500308951
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PHASE1COMPLETED
A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis
Healthy Volunteers
NCT0349326972
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PHASE1COMPLETED
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
Inflammation
NCT0324446210
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PHASE1COMPLETED
First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
Pelvic Inflammatory Disease
NCT0305440270
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Study Endpoints

Primary Endpoints

Average change of perfusion/basal flow
Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge

The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments

Average change of erythema score
Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge

The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments. Erythema score will be measured by Antera 3D camera.

Average change in TNF-α
From pre-challenge up to 6 hour after the systemic challenge
Average change in IL-6
From pre-challenge up to 6 hour after the systemic challenge
Frequency of treatment-emergent adverse events (TEAEs)
Approximately 47 days

Part 1 in healthy male subject

Severity of treatment-emergent adverse events (TEAEs)
Approximately 47 days

Part 1 in healthy male subject

AUC(0-24)md of BAY1834845
Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

AUC(0-12)md of BAY1834845
Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing

Cmax,md of BAY1834845
Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

Cav,md of BAY1834845
Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

Part 1 Cav:Average concentration within a dosing interval after multiple dosing

Cav, md of BAY1834845
Part 2: one day between day 35 and 42

Part 2: Cav: Average concentration within a dosing interval after multiple dosing

AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
Multiple timepoints up to day 7

in study part A

Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
Multiple timepoints up to day 7

in study part A

Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
Multiple timepoints up to day 7

in study part A

Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
Multiple timepoints up to day 7

in study part A

Absolute oral bioavailability (F) of BAY1834845 in the fasted state
Multiple timepoints up to day 7

in study part A

AUC of methotrexate in plasma in presence/absence of BAY1834845
Multiple timepoints up to day 2

in study part B

Cmax of methotrexate in plasma in presence/absence of BAY1834845
Multiple timepoints up to day 2

in study part B

Severity of treatment-emergent adverse events
Up to 25 days after last drug administration

The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe

Area under the plasma concentration vs. time curve (AUC)
Baseline to up to 14 days post drug administration

AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)

Maximum drug concentration in plasma after single dose administration (Cmax)
Baseline to up to 14 days post drug administration

Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845

Secondary Endpoints

Change of perfusion/basal flow
Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Change of erythema score
Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Average change of Clinician Erythema Assessment (CEA) score
Pre-challenge and at 24 hour / 48 hour / 72 hour after first administration of skin challenge
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
BAY1834845 armEXPERIMENTALBAY1834845 will be administered twice daily for 7 consecutive days (Days 1 - 7).
BAY1830839 armEXPERIMENTALBAY1830839 will be administered twice daily for 7 consecutive days (Days 1 - 7).
Prednisolone armACTIVE_COMPARATORPrednisolone will be administered twice daily for 7 consecutive days (Days 1 - 7).
Placebo armPLACEBO_COMPARATORPlacebo will be administered twice daily for 7 consecutive days (Days 1 - 7).
BAY1834845EXPERIMENTALPart 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)
Matching PlaceboPLACEBO_COMPARATORPart 1: Matching placebo in healthy male subjects.
Chosen dose of BAY1834845EXPERIMENTALPart 2: This dose level will be adminstered in female and male patients with psoriasis
PlaceboPLACEBO_COMPARATORPart 2: The placebo will be adminstered in female and male patients with psoriasis
Oral BAY1834845EXPERIMENTALStudy Part A, cross over sequence: 1. single oral dose of BAY1834845 2. single oral dose of BAY1834845 + i.v. BAY1834845 3. single oral dose of BAY1834845 under fed conditions
Oral BAY1834845 + i.v. BAY1834845EXPERIMENTALStudy Part A, cross over sequence: 1. single oral dose of BAY1834845+ i.v. BAY1834845 2. single oral dose of BAY1834845 3. single oral dose of BAY1834845 under fed conditions
Oral MethotrexateEXPERIMENTALStudy part B, cross over sequence: 1. single oral dose of methotrexate (MTX) 2. single oral dose of MTX + single oral dose of BAY1834845
Oral Methotrexate + oral BAY1834845EXPERIMENTALStudy part B, cross over sequence: 1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845 2. single oral dose of MTX
Dose escalation/BAY1834845EXPERIMENTALSubjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Interventions

NameTypeDescription
BAY1834845DRUGTablet, oral.
BAY1830839DRUGTablet, oral.
PrednisoloneDRUGTablet, oral.
PlaceboDRUGTablet, oral.
Matching PlaceboOTHEROrally administered.
MidazolamDRUGPart 1: Orally administered 1mg as a single dose.
MethotrexateDRUGSingle dose of commercially available MTX
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation including medical and surgical history, physical examination, laboratory tests, ECG and vital signs. * Participant has Fitzpa...

Countries:NetherlandsGermany
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Frequently asked questions about BAY1834845

What is BAY1834845 used for?

BAY1834845 is an investigational small molecule being developed by Bayer AG for immune mediated inflammatory diseases, including psoriasis and pelvic inflammatory disease. It has been studied in healthy volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is in Phase 1 clinical development and is not yet approved.

How does BAY1834845 work?

BAY1834845 is a small molecule being studied for its effects on inflammation in immune mediated inflammatory diseases. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated to understand how it affects inflammatory pathways when taken orally.

Who makes BAY1834845?

BAY1834845 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the drug's safety and efficacy in inflammatory conditions. The company's stock is traded under the ticker BAYRY on the over-the-counter market.

What phase is BAY1834845 in?

BAY1834845 is in Phase 1 clinical development. All four clinical trials for the drug have been completed, with no active trials currently ongoing. The drug is investigational and has not received FDA approval. It is being studied in healthy volunteers and patients with inflammatory conditions.

What clinical trials is BAY1834845 in?

BAY1834845 has been studied in four completed Phase 1 trials. These include NCT03054402, a first-in-human study in healthy males; NCT03244462, a food effect and drug interaction study; NCT03493269, a multiple dose study in healthy subjects and psoriasis patients; and NCT05003089, a study combining BAY1834845 with BAY1830839 in healthy males.

Is BAY1834845 the same as BAY1830839?

No, BAY1834845 and BAY1830839 are different investigational drugs. They were studied together in a clinical trial (NCT05003089) to learn how each affects inflammation when taken orally twice daily for 7 days in healthy male participants. Both are being developed by Bayer AG for inflammatory conditions.