Endometriosis Related PainPhase 1NCT04265781
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
A Phase 1 study testing BAY1817080 in people with Endometriosis Related Pain and Overactive Bladder, run by Bayer at 1 site in Japan.
Trial summary
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain
- What is being tested?
- BAY1817080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 15 Feb 2020to 20 Sep 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 20 to 45 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, vital signs, laboratory tests, and ECG.
- Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years
- Race: Japanese.
- BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after the last administration of study intervention.
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 by the investigator to be of clinical relevance
- Relevant diseases potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization
- Any febrile illness within the four weeks before screening or between screening and randomization
- Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- Known or suspected malignant tumors or carcinoma in situ
- Any history of malignant tumors
- Any known or suspected benign tumors of the liver and/or pituitary gland
- Known liver disease: existing acute or chronic progressive liver disease, e.g. disturbance of bilirubin excretion (Dubin-Johnson and Rotor syndromes); disturbances of bile secretion and flow (cholestasis); presence or history of liver tumors (benign or malignant). Note: According to this criterion there must have been an interval of at least 6 months between the subsidence of any viral hepatitis (normalization of liver parameters) and the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Dose Escalation Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 1817080 in Japanese Healthy Adult Male Participants in a Single-center, Randomized, Single-blind, Placebo-controlled Design
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes.
Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Being tested
- BAY1817080, Matching Placebo
- Keywords
- Refractory or unexplained chronic cough, Healthy volunteers, P2X3 receptor antagonist
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1817080Drug
Three different doses over the course of study
Matching PlaceboDrug
Matching Placebo to BAY1817080
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation BAY1817080 | Experimental | Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1. Receives: Drug: BAY1817080 |
| Dose expansion BAY1817080 | Experimental | Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14. Receives: Drug: BAY1817080 |
| Dose escalation Placebo | Placebo comparator | Participants receive placebo tablets orally as a single dose on Day 1. Receives: Drug: Matching Placebo |
| Dose expansion Placebo | Placebo comparator | Participants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-emergent adverse events (TEAE) after single dose of BAY1817080
Measured: Up to 14 days
Severity of treatment-emergent adverse events after single dose of BAY1817080
Measured: Up to 14 days
Frequency of treatment-emergent adverse events after multiple doses of BAY1817080
Measured: Up to 27 days
Severity of treatment-emergent adverse events after multiple doses of BAY1817080
Measured: Up to 27 days
Secondary outcomes (4)
Maximum plasma concentration of BAY1817080 after single dose (Cmax)
Measured: At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Area under the concentration-time curve of BAY1817080 after single dose (AUC)
In the case of extrapolated portion of AUC exceeding20% [%AUC(tlast-∞) >20%], the parameter AUC(0-tlast) may be evaluated as main parameter
Measured: At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Maximum plasma concentration of BAY1817080 after multiple doses (Cmax,md)
Measured: At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23
Area under the concentration-time curve of BAY1817080 after multiple dose (AUCτ,md)
Measured: At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start15 Feb 2020
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
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 Endometriosis Related PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265781
- Sponsor's protocol ID
- 19738
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share data. Interested researchers can use www.vivli.org 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 member section of the portal.
Publications
Li X, Haranaka M, Li H, Liu P, Chen H, Klein S, Reif S, Francke K, Friedrich C, Okumura K. P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants. Clin Pharmacokinet. 2024 Jun;63(6):901-915. doi: 10.1007/s40262-024-01387-y. Epub 2024 Jun 21.
PubMed 38907175
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Escalation Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 1817080 in Japanese Healthy Adult Male Participants in a Single-center, Randomized, Single-blind, Placebo-controlled Design
- ClinicalTrials.gov ID
- NCT04265781
- Acronym / sponsor ID
- 19738
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Keywords
- Refractory or unexplained chronic cough, Healthy volunteers, P2X3 receptor antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 12 Feb 2020 (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 in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes.
Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation BAY1817080 | Experimental | Drug: BAY1817080Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1. |
| Dose expansion BAY1817080 | Experimental | Drug: BAY1817080Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14. |
| Dose escalation Placebo | Placebo comparator | Drug: Matching PlaceboParticipants receive placebo tablets orally as a single dose on Day 1. |
| Dose expansion Placebo | Placebo comparator | Drug: Matching PlaceboParticipants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 20 to 45 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, vital signs, laboratory tests, and ECG.
- Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years
- Race: Japanese.
- BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit.
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 by the investigator to be of clinical relevance
- Relevant diseases potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization
- Any febrile illness within the four weeks before screening or between screening and randomization
- Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- Known or suspected malignant tumors or carcinoma in situ
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 |
|---|---|---|
| BAY1817080Three different doses over the course of study | Drug | Dose escalation BAY1817080, Dose expansion BAY1817080 |
| Matching PlaceboMatching Placebo to BAY1817080 | Drug | Dose escalation Placebo, Dose expansion Placebo |
Primary outcome
Frequency of treatment-emergent adverse events (TEAE) after single dose of BAY1817080
Time frame: Up to 14 days
Severity of treatment-emergent adverse events after single dose of BAY1817080
Time frame: Up to 14 days
Frequency of treatment-emergent adverse events after multiple doses of BAY1817080
Time frame: Up to 27 days
Severity of treatment-emergent adverse events after multiple doses of BAY1817080
Time frame: Up to 27 days
4 secondary outcomes
Maximum plasma concentration of BAY1817080 after single dose (Cmax)
Time frame: At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Area under the concentration-time curve of BAY1817080 after single dose (AUC)
Time frame: At 0 hour before study drug administration and up to 15 hours after study drug administration at Day 1 and at 0 hours on Day 2 to Day 10
Maximum plasma concentration of BAY1817080 after multiple doses (Cmax,md)
Time frame: At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23
Area under the concentration-time curve of BAY1817080 after multiple dose (AUCτ,md)
Time frame: At 0 hours before drug administration and up to 12 hours after drug administration on Day 1, at 0 hours from Day 2 to Day 9 and from Day 11 to Day 12, at 0 and 12 hours on Day 13, at 0 hours until 15 hours on Day 14, and at 0 hours from Day 15 to Day 23
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 Jan 2023.
- Derived from this study: PubMed 38907175Li X, Haranaka M, Li H, Liu P, Chen H, Klein S, Reif S, Francke K, Friedrich C, Okumura K. P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants. Clin Pharmacokinet. 2024 Jun;63(6):901-915. doi: 10.1007/s40262-024-01387-y. Epub 2024 Jun 21.
- Individual participant dataSharing planned: No. There are no current plans to share data. Interested researchers can use www.vivli.org 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 member 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 BAY1817080 in people with Endometriosis Related Pain and Overactive Bladder, run by Bayer at 1 site in Japan.
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 7 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 Jan 2023. 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 Japan. 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 (TEAE) after single dose of BAY1817080 (time frame: Up to 14 days). 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 NCT04265781, 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 26 Jan 2023.