NCT03054402

Brief Summary

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

February 13, 2017

Last Update Submit

March 26, 2019

Conditions

Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (4)

  • Frequency of treatment-emergent adverse events (TEAEs)

    AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.

    Up to 25 days after last drug administration

  • Severity of treatment-emergent adverse events

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

    Up to 25 days after last drug administration

  • Area under the plasma concentration vs. time curve (AUC)

    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)

    Baseline to up to 14 days post drug administration

  • Maximum drug concentration in plasma after single dose administration (Cmax)

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

    Baseline to up to 14 days post drug administration

Study Arms (2)

Dose escalation/BAY1834845

EXPERIMENTAL

Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Drug: BAY1834845

Placebo

PLACEBO COMPARATOR

Subjects will receive a single dose of placebo in the morning of the PK profile day

Drug: Placebo

Interventions

BAY1834845DRUG

Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group

Dose escalation/BAY1834845
PlaceboDRUG

Single dose of placebo

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subject
  • Age: 18 to 50 years (inclusive) at the first screening visit
  • Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

You may not qualify if:

  • Clinically relevant findings in the physical examination
  • Relevant diseases within the last 4 weeks prior to the first study drug administration
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, 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: 40520205DERIVED

Related Links

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Interventions

zabedosertib

Condition Hierarchy (Ancestors)

Pelvic InfectionInfectionsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

February 13, 2017

Primary Completion

November 30, 2017

Study Completion

March 29, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

DE(1)