EndometriosisPhase 1NCT05517746
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
A Phase 1 study testing BAY2395840 tablet and BAY2395840 oral solution in people with Endometriosis, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- BAY2395840 tablet and BAY2395840 oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 18 Dec 2019to 11 Mar 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent.
- Body mass index (BMI) ≥18 kg/m^2 and ≤30 kg/m^2.
- Participants who are overtly healthy.
- Race: White.
- Male participants of reproductive potential who are sexually active must agree to use contraception methods.
Who cannot join
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- Any known disease that was forbidden in the study as specified in study protocol.
- Any medication or drug use that was forbidden in the study as specified in study protocol.
- Any abnormal finding in Electrocardiogram (ECG), blood pressure or heart rate.
- Any clinical relevant deviation from normal range of laboratory parameters at screening.
- History of COVID-19.
- Prior contact with SARS-CoV-2 positive person or COVID-19 patient within the last 4 weeks prior admission to the ward.
- Positive SARS-CoV-2 viral RNA test.
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 and Pharmacokinetics of Increasing Single and Multiple Oral Doses of BAY 2395840 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY 2395840 in Healthy Men
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans.
In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men.
Read more
All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2.
The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks.
During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
- Conditions
- Endometriosis
- Being tested
- BAY2395840 tablet, BAY2395840 oral solution, Placebo oral solution, Placebo tablet
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2395840 tabletDrug
tablets, oral administration
BAY2395840 oral solutionDrug
solution, oral administration
Placebo oral solutionDrug
Placebo matching BAY2395840, oral administration
Placebo tabletDrug
Placebo matching BAY2395840, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2) Receives: Drug: BAY2395840 tablet; Drug: BAY2395840 oral solution |
| Group 2 | Experimental | Participants received BAY2395840 dose C as tablets under diet 1 conditions. Receives: Drug: BAY2395840 tablet |
| Group 3 | Experimental | Participants received BAY2395840 dose E as tablets under diet 1 conditions. Receives: Drug: BAY2395840 tablet |
| Group 4 | Experimental | Participants received BAY2395840 dose H as tablets under diet 1 conditions Receives: Drug: BAY2395840 tablet |
| Group 5 | Experimental | Participants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions Receives: Drug: BAY2395840 tablet |
| Group 6 | Experimental | Participants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions Receives: Drug: BAY2395840 tablet |
| Group 7 | Experimental | Participants received BAY2395840 dose I as tablets under diet 1 conditions Receives: Drug: BAY2395840 tablet |
| Group 8 | Experimental | Participants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions Receives: Drug: BAY2395840 tablet |
| Placebo matching Group 1 | Placebo comparator | Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2) Receives: Drug: Placebo oral solution; Drug: Placebo tablet |
| Placebo matching Group 2 to 4 and Group 7 | Placebo comparator | Participants received a dose of Placebo as tablets under diet 1 conditions Receives: Drug: Placebo tablet |
| Placebo matching Group 5 and 6 | Placebo comparator | Participants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions Receives: Drug: Placebo tablet |
| Placebo matching Group 8 | Placebo comparator | Participants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions. Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Measured: Up to 14 days after end of treatment with study medication in the respective period.
Number of participants with treatment-emergent adverse events, categorized by severity.
Measured: Up to 14 days after end of treatment with study medication in the respective period.
Secondary outcomes (5)
Maximum observed drug concentration in plasma (Cmax) after single dose of BAY2395840
Measured: Predose up to 192 hours
Area under the concentration vs. time curve from zero to infinity (AUC) in plasma after single dose of BAY2395840
Measured: Predose up to 192 hours
Area under the plasma concentration-time curve from zero to 24 hours AUC (0-24) after single dose of BAY2395840
AUC from time 0 to 24 hours
Measured: Pre-dose and up to 24 hours post dose
Maximum observed drug concentration in plasma (Cmax) after multiple doses of BAY2395840
Measured: Predose up to 192 hours
Area under the plasma concentration-time curve over the last 24-h dosing interval AUC(0-24)in plasma after multiple doses of BAY2395840
AUC from time 0 to 24 hours
Measured: Pre-dose and up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start18 Dec 2019
- Primary completion17 Dec 2020
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517746
- Sponsor's protocol ID
- 19634
- Other IDs
- 2019-002573-65, 2019
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. 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 and Pharmacokinetics of Increasing Single and Multiple Oral Doses of BAY 2395840 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY 2395840 in Healthy Men
- ClinicalTrials.gov ID
- NCT05517746
- Acronym / sponsor ID
- 19634
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 26 Aug 2022 (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.
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans.
In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men.
All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2.
The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks.
During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BAY2395840 tablet, Drug: BAY2395840 oral solutionParticipants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2) |
| Group 2 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose C as tablets under diet 1 conditions. |
| Group 3 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose E as tablets under diet 1 conditions. |
| Group 4 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose H as tablets under diet 1 conditions |
| Group 5 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 6 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 7 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose I as tablets under diet 1 conditions |
| Group 8 | Experimental | Drug: BAY2395840 tabletParticipants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions |
| Placebo matching Group 1 | Placebo comparator | Drug: Placebo oral solution, Drug: Placebo tabletParticipants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2) |
| Placebo matching Group 2 to 4 and Group 7 | Placebo comparator | Drug: Placebo tabletParticipants received a dose of Placebo as tablets under diet 1 conditions |
| Placebo matching Group 5 and 6 | Placebo comparator | Drug: Placebo tabletParticipants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Placebo matching Group 8 | Placebo comparator | Drug: Placebo tabletParticipants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent.
- Body mass index (BMI) ≥18 kg/m^2 and ≤30 kg/m^2.
- Participants who are overtly healthy.
- Race: White.
- Male participants of reproductive potential who are sexually active must agree to use contraception methods.
Key exclusion criteria (8 listed)
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- Any known disease that was forbidden in the study as specified in study protocol.
- Any medication or drug use that was forbidden in the study as specified in study protocol.
- Any abnormal finding in Electrocardiogram (ECG), blood pressure or heart rate.
- Any clinical relevant deviation from normal range of laboratory parameters at screening.
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 |
|---|---|---|
| BAY2395840 tablettablets, oral administration | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8 |
| BAY2395840 oral solutionsolution, oral administration | Drug | Group 1 |
| Placebo oral solutionPlacebo matching BAY2395840, oral administration | Drug | Placebo matching Group 1 |
| Placebo tabletPlacebo matching BAY2395840, oral administration | Drug | Placebo matching Group 1, Placebo matching Group 2 to 4 and Group 7, Placebo matching Group 5 and 6, Placebo matching Group 8 |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: Up to 14 days after end of treatment with study medication in the respective period.
Number of participants with treatment-emergent adverse events, categorized by severity.
Time frame: Up to 14 days after end of treatment with study medication in the respective period.
5 secondary outcomes
Maximum observed drug concentration in plasma (Cmax) after single dose of BAY2395840
Time frame: Predose up to 192 hours
Area under the concentration vs. time curve from zero to infinity (AUC) in plasma after single dose of BAY2395840
Time frame: Predose up to 192 hours
Area under the plasma concentration-time curve from zero to 24 hours AUC (0-24) after single dose of BAY2395840
Time frame: Pre-dose and up to 24 hours post dose
Maximum observed drug concentration in plasma (Cmax) after multiple doses of BAY2395840
Time frame: Predose up to 192 hours
Area under the plasma concentration-time curve over the last 24-h dosing interval AUC(0-24)in plasma after multiple doses of BAY2395840
Time frame: Pre-dose and up to 24 hours post dose
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 26 Aug 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAY2395840 tablet and BAY2395840 oral solution in people with Endometriosis, 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 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 26 Aug 2022. 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?
Number of participants with treatment-emergent adverse events (time frame: Up to 14 days after end of treatment with study medication in the respective period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022.