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

NCT03493269 | Completed Phase 1

• 2 other identifiers: 183852017-001817-10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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 psoriasis (Part 2).

Conditions

Healthy Volunteers; Psoriasis

Outcome Measures

Primary Outcomes (12)

• Frequency of treatment-emergent adverse events (TEAEs)

  Part 1 in healthy male subject

  Approximately 47 days

• Severity of treatment-emergent adverse events (TEAEs)

  Part 1 in healthy male subject

  Approximately 47 days

• Frequency of treatment-emergent adverse events (TEAEs)

  Part 2: Patients with psoriasis

  Approximately 84 days

• Severity of treatment-emergent adverse events (TEAEs)

  Part 2: Patients with psoriasis

  Approximately 84 days

• AUC(0-24)md of BAY1834845

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

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

• AUC(0-12)md of BAY1834845

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

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

• Cmax,md of BAY1834845

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

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

• Cav,md of BAY1834845

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

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

• AUC(0-24)md of BAY1834845

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

  Part 2: one day between day 35 and 42

• AUC(0-12)md of BAY1834845

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

  Part 2: one day between day 35 and 42

• Cmax,md of BAY1834845

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

  Part 2: one day between day 35 and 42

• Cav, md of BAY1834845

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

  Part 2: one day between day 35 and 42

Study Arms (4)

BAY1834845

EXPERIMENTAL

Part 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)

Drug: BAY1834845; Drug: Midazolam

Matching Placebo

PLACEBO COMPARATOR

Part 1: Matching placebo in healthy male subjects.

Other: Matching Placebo; Drug: Midazolam

Chosen dose of BAY1834845

EXPERIMENTAL

Part 2: This dose level will be adminstered in female and male patients with psoriasis

Drug: BAY1834845

Placebo

PLACEBO COMPARATOR

Part 2: The placebo will be adminstered in female and male patients with psoriasis

Other: Matching Placebo

Interventions

BAY1834845 DRUG

Orally administered.

BAY1834845; Chosen dose of BAY1834845

Matching Placebo OTHER

Orally administered.

Matching Placebo; Placebo

Midazolam DRUG

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

BAY1834845; Matching Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

PAREXEL GmbH

Berlin, 14050, Germany

Location

Related Publications (1)

• 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.

  PMID: 40520205 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

zabedosertib; Midazolam

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 10, 2018
• Study Start: April 16, 2018
• Primary Completion: September 16, 2020
• Study Completion: February 5, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

DE (2)