EndometriosisPhase 1NCT04027192
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
A Phase 1 study testing BAY2328065 LSF, BAY2328065 tablet and Midazolam in people with Endometriosis, run by Bayer at 1 site in Germany.
Trial summary
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. 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
- Endometriosis
- What is being tested?
- BAY2328065 LSF, BAY2328065 tablet and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2019to 16 Nov 2020
- 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
- Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
- 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 must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- The informed consent must be signed before any study specific tests or procedures are done
- Ability to understand and follow study-related instructions
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 requiring medication
- History of cardiovascular disease
- Known diseases as specified in protocol
Show all 13Show fewer
- Regular use of therapeutic or recreational drugs
- Suspicion of drug or alcohol abuse
- Smoking equal or more than 10 cigarettes/day
- Clinically relevant findings in Electrocardiogram (ECG), blood pressure, heart rate, physical examination, laboratory examination
- 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
- 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, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.
- Conditions
- Endometriosis
- Being tested
- BAY2328065 LSF, BAY2328065 tablet, Placebo LSF, Placebo tablet, Midazolam
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2328065 LSFDrug
20 mg/mL LSF (liquid service formulation), orally
BAY2328065 tabletDrug
50 mg tablet, orally
Placebo LSFDrug
Matching Placebo LSF, orally
Placebo tabletDrug
Matching Placebo tablet, orally
MidazolamDrug
1 mg per day, orally
| Study group | Role | What they receive |
|---|---|---|
| Bridging part: intervention sequence ABC or BAC | Experimental | 10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal) Receives: Drug: BAY2328065 LSF; Drug: BAY2328065 tablet |
| Multiple dose escalation part: dose 1 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Receives: Drug: BAY2328065 LSF; Drug: Placebo LSF |
| Multiple dose escalation part: dose 2 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction Receives: Drug: BAY2328065 tablet; Drug: Placebo tablet; Drug: Midazolam |
| Multiple dose escalation part: dose 3 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction Receives: Drug: BAY2328065 tablet; Drug: Placebo tablet; Drug: Midazolam |
| Multiple dose escalation part: dose 4 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction Receives: Drug: BAY2328065 tablet; Drug: Placebo tablet; Drug: Midazolam |
| Multiple dose escalation part: dose 5 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction Receives: Drug: BAY2328065 tablet; Drug: Placebo tablet; Drug: Midazolam |
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 (TEAEs)
Measured: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
Severity of TEAEs
Measured: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
AUC(0-12)md (twice daily [BID])
Measured: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
Cmax,md of BAY2328065
Measured: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start31 Jul 2019
- Primary completion11 Sep 2020
- Study completion16 Nov 2020
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
- Parallel groups
- Model description
- The study will be performed in 2 study parts. Each participant will take part in one study part only. * Bridging part: This will be a single-center, randomized, open-label cross-over part with 3 study interventions, 3 intervention periods and 2 intervention sequences. * Multiple dose escalation part: This will be a single-center, randomized, placebo-controlled, double-blind, parallel group multiple dose escalation part.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027192
- Sponsor's protocol ID
- 19251
- Other IDs
- 2019-000940-90, 2019
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2019
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT04027192
- Acronym / sponsor ID
- 19251
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 19 Jul 2019 (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.
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- The study will be performed in 2 study parts. Each participant will take part in one study part only. * Bridging part: This will be a single-center, randomized, open-label cross-over part with 3 study interventions, 3 intervention periods and 2 intervention sequences. * Multiple dose escalation part: This will be a single-center, randomized, placebo-controlled, double-blind, parallel group multiple dose escalation part.
| Arm | Type | Receives |
|---|---|---|
| Bridging part: intervention sequence ABC or BAC | Experimental | Drug: BAY2328065 LSF, Drug: BAY2328065 tablet10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal) |
| Multiple dose escalation part: dose 1 | Experimental | Drug: BAY2328065 LSF, Drug: Placebo LSF10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day |
| Multiple dose escalation part: dose 2 | Experimental | Drug: BAY2328065 tablet, Drug: Placebo tablet, Drug: Midazolam10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 3 | Experimental | Drug: BAY2328065 tablet, Drug: Placebo tablet, Drug: Midazolam10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 4 | Experimental | Drug: BAY2328065 tablet, Drug: Placebo tablet, Drug: Midazolam10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 5 | Experimental | Drug: BAY2328065 tablet, Drug: Placebo tablet, Drug: Midazolam10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
- 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 must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up
Key exclusion criteria (13 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 requiring medication
- History of cardiovascular disease
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 |
|---|---|---|
| BAY2328065 LSF20 mg/mL LSF (liquid service formulation), orally | Drug | Bridging part: intervention sequence ABC or BAC, Multiple dose escalation part: dose 1 |
| BAY2328065 tablet50 mg tablet, orally | Drug | Bridging part: intervention sequence ABC or BAC, Multiple dose escalation part: dose 2, Multiple dose escalation part: dose 3, Multiple dose escalation part: dose 4, Multiple dose escalation part: dose 5 |
| Placebo LSFMatching Placebo LSF, orally | Drug | Multiple dose escalation part: dose 1 |
| Placebo tabletMatching Placebo tablet, orally | Drug | Multiple dose escalation part: dose 2, Multiple dose escalation part: dose 3, Multiple dose escalation part: dose 4, Multiple dose escalation part: dose 5 |
| Midazolam1 mg per day, orally | Drug | Multiple dose escalation part: dose 2, Multiple dose escalation part: dose 3, Multiple dose escalation part: dose 4, Multiple dose escalation part: dose 5 |
Primary outcome
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
Severity of TEAEs
Time frame: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
AUC(0-12)md (twice daily [BID])
Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
Cmax,md of BAY2328065
Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
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 23 Nov 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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 BAY2328065 LSF, BAY2328065 tablet and Midazolam 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 8 inclusion and 13 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 23 Nov 2020. 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. 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 (TEAEs) (time frame: From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant). 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 23 Nov 2020.