EndometriosisPhase 1NCT04851483
A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants
A Phase 1 study testing BAY2328065 in people with Endometriosis, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a different way to treat women with a condition in which tissue that normally lines the uterus grows outside the uterus. This condition is called endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- BAY2328065
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 28 Apr 2021to 14 Feb 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, blood pressure and heart rate
- Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
- Body mass index (BMI) within the range 18 and 30 kg/m^2 (inclusive)
- Male participants who are sexually active and female participants of childbearing potential must use one of the methods of contraception described in this protocol
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
- Relevant diseases within the last 4 weeks prior to start of the first study intervention
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Existing chronic diseases as specified in protocol
- Regular use of therapeutic or recreational drugs
- Suspicion of drug or alcohol abuse
- Smoking equal or more than 10 cigarettes/day
- History of COVID-19; contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward or positive SARS-CoV-2 viral RNA test
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Characterization of Single Dose Bioavailability of Two Novel Formulations of BAY 2328065 in Healthy Male Participants Including Dose Proportionality of One Formulation and Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Dose Administration in Healthy Female Participants
Researchers are looking for a different way to treat women with a condition in which tissue that normally lines the uterus grows outside the uterus. This condition is called endometriosis. Before a treatment is available to all patients, researchers study it in clinical trials to better understand its safety and what happens to it in the body.
BAY2328065 is being developed to help treat women who have endometriosis. Women with endometriosis often have very painful menstrual periods, as well as pain in the pelvic area which is not related to menstrual periods and pain during intercourse. Many women with endometriosis may also have problems becoming pregnant. The trial treatment, BAY2328065, works by blocking a certain protein that causes pain and swelling of the tissue and is thought to play a role in endometriosis.
Read more
In this trial, the researchers want to compare what happens to different medicinal forms of BAY2328065 in the body. They also want to learn if eating a meal affects what happens to BAY2328065 in the body.
This trial will include about 32 men and women who are aged 18 to 55. There will be 4 groups of participants in this trial. The participants in Groups 1, 2, and 3 will be men. The participants in Group 4 will be women. There will be 3 treatment courses to the trial for Groups 1, 2 and 3 and 1 treatment course for Group 4.
During the trial, the participants in Groups 1, 2, and 3 will stay at the trial site for 15 days (3 times 5 days with times in between during which they stay at home). The participants in Group 4 will stay at the trial site for 16 days continuously. But, the trial will last about 6 weeks for the participants in Groups 1, 2, and 3. The trial will last about 9 weeks for the participants in Group 4.
All of the participants in Groups 1 and 2 will take the different medicinal forms of BAY2328065, with and without food. All of the participants in Groups 1 and 2 will take dose "2" of BAY2328065 in all 3 treatment courses. In Group 1, they will take BAY2328065 one time each during the following treatment courses:
- A medicinal form of BAY2328065 without food in treatment course 1, then
- A medicinal form of BAY2328065 differing from the one used in treatment course 1 without food in treatment course 2, then
- The medicinal form of BAY2328065 used in treatment course 1 with food in treatment course 3 The participants in Group 2 will do the same, but they will take each form of BAY2328065 in a different order. Information gathered from Group 1 and 2 will help the researchers learn which form of BAY2328065 will be most suited to give to the participants in Groups 3 and 4.
The participants in Group 3 will take 3 different doses of BAY2328065 with food in each treatment course. They will take one time each during the following treatment courses:
- Single administration of dose "1" in treatment course 1, then
- Single administration of dose "2" in treatment course 2, then
- Single administration of dose "3" in treatment course 3 This will help the researchers learn the safest dose to give to the participants in treatment course 4.
The participants in Group 4 will either take dose "3" or "2" of BAY2328065 based on the results of treatment course 3, or a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take either:
- Multiple administrations of dose "3" of BAY2328065 or dose "2" of BAY2328065, OR
- the placebo The participants will take BAY2328065 or placebo over 12 days without food.
The doctors/ healthcare staff will:
- take blood and collect urine samples
- check the participants' heart health
The participants will:
- answer questions about how they are feeling
- say if they have any medical problems
- say if they have taken any medications
- Conditions
- Endometriosis
- Being tested
- BAY2328065, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2328065Drug
Solid Form, Oral administration.
PlaceboDrug
Matching placebo of BAY2328065.
| Study group | Role | What they receive |
|---|---|---|
| Group 1_BAY2328065 _male participants | Experimental | Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). Receives: Drug: BAY2328065 |
| Group 2_BAY2328065 _male participants | Experimental | Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). Receives: Drug: BAY2328065 |
| Group 3_BAY2328065 _male participants | Experimental | Approximately 8 participants will be assigned to the study intervention with one fixed sequence. Receives: Drug: BAY2328065 |
| Group 4_BAY2328065 _female participants | Experimental | Approximately 9 participants will be randomly assigned to receive BAY2328065. Receives: Drug: BAY2328065 |
| Group 4_Placebo _female participants | Placebo comparator | Approximately 3 participants will be randomly assigned to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-emergent adverse events (TEAE)
Measured: From first administration of study intervention up to 30 days after end of treatment with study intervention
Severity of treatment-emergent adverse events (TEAEs)
Measured: From first administration of study intervention up to 30 days after end of treatment with study intervention
AUC of BAY2328065
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
Measured: From dosing up to 72 hours
Cmax of BAY2328065
Cmax: maximum observed drug concentration in measured matrix after single dose administration
Measured: From dosing up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start28 Apr 2021
- Primary completion14 Dec 2021
- Study completion14 Feb 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Study Groups 1 and 2 using a fixed sequence parallel group design * Study Group 3 using a fixed sequence design * Study Group 4 using a placebo-controlled parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851483
- Sponsor's protocol ID
- 20568
- Other IDs
- 2020-005497-96
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 1 Jun 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Single Dose Bioavailability of Two Novel Formulations of BAY 2328065 in Healthy Male Participants Including Dose Proportionality of One Formulation and Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Dose Administration in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT04851483
- Acronym / sponsor ID
- 20568
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 20 Apr 2021 (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 different way to treat women with a condition in which tissue that normally lines the uterus grows outside the uterus. This condition is called endometriosis. Before a treatment is available to all patients, researchers study it in clinical trials to better understand its safety and what happens to it in the body.
BAY2328065 is being developed to help treat women who have endometriosis. Women with endometriosis often have very painful menstrual periods, as well as pain in the pelvic area which is not related to menstrual periods and pain during intercourse. Many women with endometriosis may also have problems becoming pregnant. The trial treatment, BAY2328065, works by blocking a certain protein that causes pain and swelling of the tissue and is thought to play a role in endometriosis.
In this trial, the researchers want to compare what happens to different medicinal forms of BAY2328065 in the body. They also want to learn if eating a meal affects what happens to BAY2328065 in the body.
This trial will include about 32 men and women who are aged 18 to 55. There will be 4 groups of participants in this trial. The participants in Groups 1, 2, and 3 will be men. The participants in Group 4 will be women. There will be 3 treatment courses to the trial for Groups 1, 2 and 3 and 1 treatment course for Group 4.
During the trial, the participants in Groups 1, 2, and 3 will stay at the trial site for 15 days (3 times 5 days with times in between during which they stay at home). The participants in Group 4 will stay at the trial site for 16 days continuously. But, the trial will last about 6 weeks for the participants in Groups 1, 2, and 3. The trial will last about 9 weeks for the participants in Group 4.
All of the participants in Groups 1 and 2 will take the different medicinal forms of BAY2328065, with and without food. All of the participants in Groups 1 and 2 will take dose "2" of BAY2328065 in all 3 treatment courses. In Group 1, they will take BAY2328065 one time each during the following treatment courses:
- A medicinal form of BAY2328065 without food in treatment course 1, then
- A medicinal form of BAY2328065 differing from the one used in treatment course 1 without food in treatment course 2, then
- The medicinal form of BAY2328065 used in treatment course 1 with food in treatment course 3 The participants in Group 2 will do the same, but they will take each form of BAY2328065 in a different order. Information gathered from Group 1 and 2 will help the researchers learn which form of BAY2328065 will be most suited to give to the participants in Groups 3 and 4.
The participants in Group 3 will take 3 different doses of BAY2328065 with food in each treatment course. They will take one time each during the following treatment courses:
- Single administration of dose "1" in treatment course 1, then
- Single administration of dose "2" in treatment course 2, then
- Single administration of dose "3" in treatment course 3 This will help the researchers learn the safest dose to give to the participants in treatment course 4.
The participants in Group 4 will either take dose "3" or "2" of BAY2328065 based on the results of treatment course 3, or a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take either:
- Multiple administrations of dose "3" of BAY2328065 or dose "2" of BAY2328065, OR
- the placebo The participants will take BAY2328065 or placebo over 12 days without food.
The doctors/ healthcare staff will:
- take blood and collect urine samples
- check the participants' heart health
The participants will:
- answer questions about how they are feeling
- say if they have any medical problems
- say if they have taken any medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- * Study Groups 1 and 2 using a fixed sequence parallel group design * Study Group 3 using a fixed sequence design * Study Group 4 using a placebo-controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| Group 1_BAY2328065 _male participants | Experimental | Drug: BAY2328065Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). |
| Group 2_BAY2328065 _male participants | Experimental | Drug: BAY2328065Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). |
| Group 3_BAY2328065 _male participants | Experimental | Drug: BAY2328065Approximately 8 participants will be assigned to the study intervention with one fixed sequence. |
| Group 4_BAY2328065 _female participants | Experimental | Drug: BAY2328065Approximately 9 participants will be randomly assigned to receive BAY2328065. |
| Group 4_Placebo _female participants | Placebo comparator | Drug: PlaceboApproximately 3 participants will be randomly assigned to receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, blood pressure and heart rate
- Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
- Body mass index (BMI) within the range 18 and 30 kg/m^2 (inclusive)
- Male participants who are sexually active and female participants of childbearing potential must use one of the methods of contraception described in this protocol
Key exclusion criteria (8 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
- Relevant diseases within the last 4 weeks prior to start of the first study intervention
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Existing chronic diseases as specified in protocol
- Regular use of therapeutic or recreational drugs
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 |
|---|---|---|
| BAY2328065Solid Form, Oral administration. | Drug | Group 1_BAY2328065 _male participants, Group 2_BAY2328065 _male participants, Group 3_BAY2328065 _male participants, Group 4_BAY2328065 _female participants |
| PlaceboMatching placebo of BAY2328065. | Drug | Group 4_Placebo _female participants |
Primary outcome
Number of subjects with treatment-emergent adverse events (TEAE)
Time frame: From first administration of study intervention up to 30 days after end of treatment with study intervention
Severity of treatment-emergent adverse events (TEAEs)
Time frame: From first administration of study intervention up to 30 days after end of treatment with study intervention
AUC of BAY2328065
Time frame: From dosing up to 72 hours
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
Cmax of BAY2328065
Time frame: From dosing up to 72 hours
Cmax: maximum observed drug concentration in measured matrix after single dose administration
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 1 Jun 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.
Related trials for Endometriosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
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 BAY2328065 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 1 Jun 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 subjects with treatment-emergent adverse events (TEAE) (time frame: From first administration of study intervention up to 30 days after end of treatment with study intervention). 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?
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 1 Jun 2022.