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Endometriosis Related PainPhase 1NCT04487431

A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)

A Phase 1 study testing BAY1817080 and [14C]BAY1817080 in people with Endometriosis Related Pain and Overactive Bladder, run by Bayer at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where… Read more about this study

Who is it for?
Ages 18 to 54 years, men onlyHealthy volunteers can take part
What is being tested?
BAY1817080 and [14C]BAY1817080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteNetherlands
Study dates
5 Aug 2020to 11 Feb 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 54 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Capable of giving signed informed consent as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
  • Ability to understand and follow study-related instructions;
  • Participant has signed the ICF before any study specific tests or procedures are done;
  • Healthy male participant;
  • Age: 18 to 54 years (inclusive) at the time of informed consent and first dose of study medication;
  • Body mass index (BMI) ≥18 and ≤30 kg/m^2 at Screening;
  • Body weight of at least 45 kg at Screening;
  • Participant agrees to use contraception as described in Appendix.

Who cannot join

  • Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash;
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations);
  • Known severe allergies, e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract (e.g., allergic asthma), allergies requiring therapy with corticosteroids or significant nonallergic drug reactions;
  • Febrile illness within 1 week before study drug administration;
  • Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent occurrence of heartburn [more than once per week], or any gastrointestinal surgical intervention [e.g. cholecystectomy]);
  • Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening;
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  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of study intervention will not be normal;
  • Poor peripheral venous access;
  • Regular use of medicines within 14 days prior to administration of study intervention;
  • Regular use of therapeutic or recreational drugs, e.g., cannabis, carnitine products, anabolics, high dose vitamins within 3 months prior to screening;
  • Any use of medicines or substances within 14 days prior to administration, which oppose the study objectives or might affect the PK of BAY1817080 (e.g., laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, systemic antibiotics, CYP3A4 inducers, CYP3A4 inhibitors, "organic anion transporting polypeptide" (OATP) / "breast cancer resistance protein" (BCRP) substrates, P-gp substrates and inhibitors). Relevant medication of individual participants will be discussed with the study medical expert before first dosing in the study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRAHealthSciences

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Single-center, Open-label, Non-placebo-controlled, Single-dose Study in Healthy Male Participants to Determine the Pharmacokinetics of BAY 1817080 Oral Solution (Part A) and to Investigate the Pharmacokinetics, Metabolic Disposition and Mass Balance of [14C]BAY 1817080 Oral Solution (Part B)

Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for these conditions.

In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up by the body in a small number of healthy participants. The trial will include men who are aged 18 to 54.

The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site for about 5 days. During this time, the participants will take 1 dose of a liquid form of BAY1817080 by mouth. The doctors will take blood and urine samples and check the participants' health. Part A will be done so the researchers can see how much BAY1817080 gets into the participants' blood. The participants in Part B will stay at the trial site for about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7 days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a radioactive substance (carbon 14), which means it is "radiolabeled". This allows the researchers to understand how BAY1817080 moves through and leaves the body. During Part B, the doctors will take blood, urine, stool, and vomit samples if applicable. They will also check the participants' health.

Being tested
BAY1817080, [14C]BAY1817080
Keywords
Healthy volunteers, Pharmacokinetics (PK)
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

    Oral single dose

  • [14C]BAY1817080Drug

    Oral single dose

Study groups in NCT04487431
Study groupRoleWhat they receive
BAY1817080 Part AExperimentalHealthy male participants will receive BAY1817080 given as an oral solution (study Part A)
Receives: Drug: BAY1817080
[14C]BAY1817080 Part BExperimentalHealthy male participants will receive BAY1817080 blended with [14C]BAY1817080 given as an oral solution (study Part B).
Receives: Drug: [14C]BAY1817080

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC of BAY1817080 in plasma (Part A)

    Area under the concentration vs. time curve

    Measured: Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)

  2. Maximum observed concentration of BAY1817080 in plasma (Cmax) (Part A)

    Measured: Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)

  3. Radioactivity excreted in urine of BAY1817080 and its metabolites as a percentage of the dose (%AE,ur) (Part B)

    Measured: Pre-dose, Day 1 (0-12 h and 12-24 h), Days 2 to 15, 22, 29, 36, 43

  4. Radioactivity excreted in feces of BAY1817080 and its metabolites as a percentage of the dose (%AE,fec) (Part B)

    Measured: Pre-dose, Days 1 to 15, 22, 29, 36, 43

  5. Radioactivity excreted in vomit (if applicable) of BAY1817080 and its metabolites as a percentage of the dose (%AE,v) (Part B)

    Measured: Up to 12 hours post-dose

  6. Whole blood to plasma ratio of total radioactivity (Part B)

    Measured: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43

  7. AUC of [14C]BAY1817080 in Plasma (Part B)

    Measured: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15

  8. Cmax of [14C]BAY1817080 in plasma (Part B)

    Measured: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15

  9. AUC of total radioactivity (Part B)

    Measured: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43

  10. Cmax of total radioactivity (Part B)

    Measured: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43

Secondary outcomes (4)

  1. Number of participants with Treatment-emergent adverse events (TEAEs) (Part A)

    Measured: From first dose up to Day 15

  2. Number of participants with maximum severity of TEAEs (Part A)

    Measured: From first dose up to Day 15

  3. Number of participants with TEAEs (Part B)

    Measured: From first dose up to Day 15

  4. Number of participants with maximum severity of TEAEs (Part B)

    Measured: From first dose up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start5 Aug 2020
  3. Primary completion30 Sep 2020
  4. Study completion11 Feb 2021

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487431
Sponsor's protocol ID
20330
Other IDs
2020-000519-54
Status last verified
Jan 2023
First submitted
23 Jul 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

  • Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3.

    PubMed 38044419

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1817080 and [14C]BAY1817080 in people with Endometriosis Related Pain and Overactive Bladder, run by Bayer at 1 site in Netherlands.

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 11 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 Netherlands. 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?

AUC of BAY1817080 in plasma (Part A) (time frame: Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)). The study lists 10 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 NCT04487431, 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.

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