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Healthy VolunteersPhase 1NCT03493269

A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

A Phase 1 study testing BAY1834845 and Midazolam in people with Healthy Volunteers and Psoriasis, run by Bayer at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2). To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Psoriasis
What is being tested?
BAY1834845 and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
2 sitesGermany
Study dates
16 Apr 2018to 5 Feb 2021
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part 1 (healthy male subjects)
  • Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
  • Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)
  • Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
  • Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body weight above 50 kg
  • A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.

Who cannot join

  • History of hypersensitivity to any of the components of the study drug
  • Any clinically relevant abnormal findings in safety laboratory parameters and ECG
  • History of tuberculosis (TB) or active or latent tuberculosis
  • Receipt of live or attenuated vaccine 90 days prior to the first dosing

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité Research Organisation GmbH

    Berlin, 10117

  • PAREXEL GmbH

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).

To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

Being tested
BAY1834845, Matching Placebo, Midazolam
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1834845Drug

    Orally administered.

  • Matching PlaceboOther

    Orally administered.

  • MidazolamDrug

    Part 1: Orally administered 1mg as a single dose.

Study groups in NCT03493269
Study groupRoleWhat they receive
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)
Receives: Drug: BAY1834845; Drug: Midazolam
Matching PlaceboPlacebo comparatorPart 1: Matching placebo in healthy male subjects.
Receives: Other: Matching Placebo; Drug: Midazolam
Chosen dose of BAY1834845ExperimentalPart 2: This dose level will be adminstered in female and male patients with psoriasis
Receives: Drug: BAY1834845
PlaceboPlacebo comparatorPart 2: The placebo will be adminstered in female and male patients with psoriasis
Receives: Other: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of treatment-emergent adverse events (TEAEs)

    Part 1 in healthy male subject

    Measured: Approximately 47 days

  2. Severity of treatment-emergent adverse events (TEAEs)

    Part 1 in healthy male subject

    Measured: Approximately 47 days

  3. Frequency of treatment-emergent adverse events (TEAEs)

    Part 2: Patients with psoriasis

    Measured: Approximately 84 days

  4. Severity of treatment-emergent adverse events (TEAEs)

    Part 2: Patients with psoriasis

    Measured: Approximately 84 days

  5. AUC(0-24)md of BAY1834845

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

    Measured: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

  6. AUC(0-12)md of BAY1834845

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

    Measured: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

  7. Cmax,md of BAY1834845

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

    Measured: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

  8. Cav,md of BAY1834845

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

    Measured: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

  9. AUC(0-24)md of BAY1834845

    Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

    Measured: Part 2: one day between day 35 and 42

  10. AUC(0-12)md of BAY1834845

    Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing

    Measured: Part 2: one day between day 35 and 42

  11. Cmax,md of BAY1834845

    Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

    Measured: Part 2: one day between day 35 and 42

  12. Cav, md of BAY1834845

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

    Measured: Part 2: one day between day 35 and 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start16 Apr 2018
  3. Primary completion16 Sep 2020
  4. Study completion5 Feb 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493269
Sponsor's protocol ID
18385
Other IDs
2017-001817-10, 2017
Status last verified
Feb 2021
First submitted
4 Apr 2018
Last updated
26 Feb 2021
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1834845 and Midazolam in people with Healthy Volunteers and Psoriasis, run by Bayer at 2 sites in Germany.

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 6 inclusion and 4 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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?

Frequency of treatment-emergent adverse events (TEAEs) (time frame: Approximately 47 days). The study lists 12 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 NCT03493269, 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 26 Feb 2021.

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