Pelvic Inflammatory DiseasePhase 1NCT03054402
First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
A Phase 1 study testing BAY1834845 in people with Pelvic Inflammatory Disease, run by Bayer at 1 site in Germany.
Trial 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. 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
- Pelvic Inflammatory Disease
- What is being tested?
- BAY1834845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 13 Feb 2017to 29 Mar 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
- Healthy male subject
- Age: 18 to 50 years (inclusive) at the first screening visit
- Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers
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.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- BAY1834845, Placebo
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1834845Drug
Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
PlaceboDrug
Single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation/BAY1834845 | Experimental | Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day Receives: Drug: BAY1834845 |
| Placebo | Placebo comparator | Subjects will receive a single dose of placebo in the morning of the PK profile day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline to up to 14 days post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start13 Feb 2017
- Primary completion30 Nov 2017
- Study completion29 Mar 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 Pelvic Inflammatory DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 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
- NCT03054402
- Sponsor's protocol ID
- 18384
- Other IDs
- 2016-002668-15, 2016
- Status last verified
- Mar 2019
- First submitted
- 13 Feb 2017
- Last updated
- 27 Mar 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 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03054402
- Acronym / sponsor ID
- 18384
- Conditions
- Pelvic Inflammatory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 15 Feb 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation/BAY1834845 | Experimental | Drug: BAY1834845Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single dose of placebo in the morning of the PK profile day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subject
- Age: 18 to 50 years (inclusive) at the first screening visit
- Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| BAY1834845Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group | Drug | Dose escalation/BAY1834845 |
| PlaceboSingle dose of placebo | Drug | Placebo |
Primary outcome
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: Up to 25 days after last drug administration
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.
Severity of treatment-emergent adverse events
Time frame: 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)
Time frame: 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)
Time frame: Baseline to up to 14 days post drug administration
Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845
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 27 Mar 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 in people with Pelvic Inflammatory Disease, run by Bayer at 1 site 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 3 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 27 Mar 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 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: Up to 25 days after last drug administration). The study lists 4 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 NCT03054402, 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 27 Mar 2019.