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Endometriosis Related PainPhase 1NCT04471337

Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function

A Phase 1 study testing BAY1817080 in people with Endometriosis Related Pain and Overactive Bladder, run by Bayer at 2 sites in United States.

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

BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
What is being tested?
BAY1817080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
12 Aug 2020to 6 May 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 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
  • For renally impaired participants:
  • Decreased renal function, as assessed based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m^2; or ESRD on dialysis.
  • Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening.
  • For participants with normal renal function:
  • -- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI : eGFR ≥90 mL/min/1.73 m^2.
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  • Body mass index (BMI) within the range 18 to 38 kg/m^2 (both inclusive)
  • Women of childbearing potential (WOCBP) must agree to use contraception for the duration of the study. This applies for the time period between signing of the Informed Consent Form until at least 30 days after the last dose of the study drug.
  • Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.
  • Acute renal failure or acute nephritis within the past 2 years
  • Use of strong CYP3A4 and P-glycoprotein inhibitors from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
  • Use of CYP3A4 and P-glycoprotein inducers from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
  • Use of drugs which may affect absorption (e.g. loperamide, metoclopramide), and systemic administration of any broad-spectrum antibiotic within 1 week before first study drug administration, unless the drug is part of the mandatory dosing regimen for treatment of renal impairment or related conditions.
  • International Normalized Ratio (INR) > 2.3.
  • Indication or evidence for long QT syndrome; Participants in control group only: QT interval corrected using Fridericia's method (QTcF) > 450 msec.
  • Inability to provide informed consent: Participants with psychiatric disorders.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of BAY 1817080 in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal Function

BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.

Being tested
BAY1817080
Keywords
Normal renal function, Moderate renal impairment, End stage renal disease (ESRD), Dialysis
Medical subject headings
Urinary Bladder, Overactive, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1817080Drug

    BAY1817080 will be administered orally as tablet.

Study groups in NCT04471337
Study groupRoleWhat they receive
Arm A: Moderately impaired renal functionExperimentalParticipants with moderately impaired renal function will receive multiple doses of BAY1817080.
Receives: Drug: BAY1817080
Arm B: Normal renal function matched to Arm AExperimentalParticipants with normal renal function matched to Arm A will receive multiple doses of BAY1817080.
Receives: Drug: BAY1817080
Arm C: End stage renal disease on dialysisExperimentalParticipants with ESRD requiring dialysis will receive single dose of BAY1817080.
Receives: Drug: BAY1817080
Arm D: Normal renal function matched to Arm CExperimentalParticipants with normal renal function matched to Arm C will receive single dose of BAY1817080.
Receives: Drug: BAY1817080

What is being measured

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

  1. AUCu after single dose of BAY1817080

    AUCu: Area under the Curve unbound

    Measured: On Day 1

  2. Cmax,u after single dose of BAY1817080

    Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)

    Measured: On Day 1

Secondary outcomes (3)

  1. Number of subjects with treatment emergent adverse events (TEAEs)

    Measured: From dosing up to 14 days after end of treatment with study medication

  2. AUC (0-12)md,u after multiple dose of BAY1817080

    Area under the time curve from 0-12 hours at steady state for the multiple dose (unbound)

    Measured: From Day 6 to Day 13

  3. Cmax,md,u after multiple dose of BAY1817080

    Cmax,md,u: Maximum observed drug concentration at steady state for multiple dose (unbound)

    Measured: From Day 6 to Day 13

Timeline

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

  1. First posted15 Jul 2020
  2. Study start12 Aug 2020
  3. Primary completion15 Feb 2021
  4. Study completion6 May 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
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04471337
Sponsor's protocol ID
20332
Status last verified
Mar 2024
First submitted
10 Jul 2020
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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.

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 2 sites in United States.

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 9 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

AUCu after single dose of BAY1817080 (time frame: On Day 1). 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?

On the ClinicalTrials.gov record for NCT04471337.

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 Mar 2024.

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