InflammationPhase 1NCT03244462
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate
A Phase 1 study testing BAY1834845 and Methotrexate in people with Inflammation, run by Bayer at 1 site in Netherlands.
Trial summary
This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- BAY1834845 and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Aug 2017to 20 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male; healthy according to complete medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria given below.
- Age 18-50 years (inclusive) at the first screening visit.
- Body mass index: >=18 kg/m² and <=30 kg/m².
- Sexually active men must agree to practice adequate methods of contraception (protection).
- This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).
Who cannot join
- Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
- Medication history: drugs known to induce/inhibit liver enzymes
- Smoking
- Clinically relevant findings in
- physical
- ECG, blood pressure
- laboratory values
- Known hypersensitivity to study drug(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Cross-over Study to Explore the Pharmacokinetics of BAY1834845 After Oral and Intravenous Dosing, Including Food Effect and Absolute Bioavailability (Part A), and to Investigate the Effect of BAY1834845 on the Pharmacokinetics of Orally Administered Methotrexate (Part B) in Healthy Male Subjects
This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
- Conditions
- Inflammation
- Being tested
- BAY1834845, Methotrexate
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1834845Drug
Single oral dose (IR [immediate release] tablets)
BAY1834845Drug
I.v. infusion of [13C6]-labeled BAY1834845
MethotrexateDrug
Single dose of commercially available MTX
| Study group | Role | What they receive |
|---|---|---|
| Oral BAY1834845 | Experimental | Study 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 Receives: Drug: BAY1834845 |
| Oral BAY1834845 + i.v. BAY1834845 | Experimental | Study 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 Receives: Drug: BAY1834845 |
| Oral Methotrexate | Experimental | Study part B, cross over sequence:
1. single oral dose of methotrexate (MTX)
2. single oral dose of MTX + single oral dose of BAY1834845 Receives: Drug: BAY1834845; Drug: Methotrexate |
| Oral Methotrexate + oral BAY1834845 | Experimental | Study part B, cross over sequence:
1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845
2. single oral dose of MTX Receives: Drug: BAY1834845; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
in study part A
Measured: Multiple timepoints up to day 7
Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
in study part A
Measured: Multiple timepoints up to day 7
Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
in study part A
Measured: Multiple timepoints up to day 7
Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
in study part A
Measured: Multiple timepoints up to day 7
Absolute oral bioavailability (F) of BAY1834845 in the fasted state
in study part A
Measured: Multiple timepoints up to day 7
AUC of methotrexate in plasma in presence/absence of BAY1834845
in study part B
Measured: Multiple timepoints up to day 2
Cmax of methotrexate in plasma in presence/absence of BAY1834845
in study part B
Measured: Multiple timepoints up to day 2
Secondary outcomes (4)
Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
Measured: Up to 9 weeks
Severity of TEAEs in part A
Measured: Up to 9 weeks
Frequency of TEAEs in part B
Measured: Up to 6 weeks
Severity of TEAEs in part B
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start18 Aug 2017
- Primary completion22 Jan 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244462
- Sponsor's protocol ID
- 18387
- Other IDs
- 2016-004393-18, 2016
- Status last verified
- Jul 2019
- First submitted
- 7 Aug 2017
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025.
PubMed 40520205
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Cross-over Study to Explore the Pharmacokinetics of BAY1834845 After Oral and Intravenous Dosing, Including Food Effect and Absolute Bioavailability (Part A), and to Investigate the Effect of BAY1834845 on the Pharmacokinetics of Orally Administered Methotrexate (Part B) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03244462
- Acronym / sponsor ID
- 18387
- Conditions
- Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral BAY1834845 | Experimental | Drug: BAY1834845Study 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. BAY1834845 | Experimental | Drug: BAY1834845Study 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 Methotrexate | Experimental | Drug: BAY1834845, Drug: MethotrexateStudy 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 BAY1834845 | Experimental | Drug: BAY1834845, Drug: MethotrexateStudy part B, cross over sequence: 1. single oral dose of methotrexate (MTX) + single oral dose of BAY1834845 2. single oral dose of MTX |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male; healthy according to complete medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria given below.
- Age 18-50 years (inclusive) at the first screening visit.
- Body mass index: >=18 kg/m² and <=30 kg/m².
- Sexually active men must agree to practice adequate methods of contraception (protection).
- This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).
Key exclusion criteria (8 listed)
- Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
- Medication history: drugs known to induce/inhibit liver enzymes
- Smoking
- Clinically relevant findings in
- Known hypersensitivity to study drug(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY1834845Single oral dose (IR [immediate release] tablets) | Drug | Oral BAY1834845, Oral BAY1834845 + i.v. BAY1834845, Oral Methotrexate, Oral Methotrexate + oral BAY1834845 |
| BAY1834845I.v. infusion of [13C6]-labeled BAY1834845 | Drug | Oral BAY1834845, Oral BAY1834845 + i.v. BAY1834845 |
| MethotrexateSingle dose of commercially available MTX | Drug | Oral Methotrexate, Oral Methotrexate + oral BAY1834845 |
Primary outcome
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
Time frame: 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
Time frame: Multiple timepoints up to day 7
in study part A
Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
Time frame: Multiple timepoints up to day 7
in study part A
Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
Time frame: Multiple timepoints up to day 7
in study part A
Absolute oral bioavailability (F) of BAY1834845 in the fasted state
Time frame: Multiple timepoints up to day 7
in study part A
AUC of methotrexate in plasma in presence/absence of BAY1834845
Time frame: Multiple timepoints up to day 2
in study part B
Cmax of methotrexate in plasma in presence/absence of BAY1834845
Time frame: Multiple timepoints up to day 2
in study part B
4 secondary outcomes
Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
Time frame: Up to 9 weeks
Severity of TEAEs in part A
Time frame: Up to 9 weeks
Frequency of TEAEs in part B
Time frame: Up to 6 weeks
Severity of TEAEs in part B
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 40520205Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1834845 and Methotrexate in people with Inflammation, run by Bayer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Multiple timepoints up to day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.