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AzTrials

Endometriosis Related PainPhase 1NCT04454424

Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function

A Phase 1 study testing BAY1817080 and Midazolam 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 years
What is being tested?
BAY1817080 and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
23 Jul 2020to 15 Dec 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
  • No healthy volunteers
  • 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.
  • Participants with a medical history of chronic (For Hepatically Impaired Participants only):
  • documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, CT, MRI or ultrasound, AND
  • hepatic impairment (Child-Pugh A or B or C), AND
  • stable liver disease, i.e. same Child-Pugh class for at least 2 months prior to screening.
  • Body mass index (BMI) within the range 18 to 38 kg/m^2 (both inclusive).
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  • Male or female.
  • 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 hepatic impairment for the hepatic impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.
  • Renal failure with an estimated glomerular filtration rate (eGFR) ≤ 35 mL/min, according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • 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 hepatic impairment or related conditions.
  • Indication or evidence for long QT syndrome; Participants in control arm only: QT interval corrected using Fridericia's method (QTcF) > 450 msec.
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  • Ascites qualitatively estimated as severe ascites by physical examination, with need of paracentesis; or a recent history of paracentesis.
  • Alkaline phosphatase (AP) ≥4 times the upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in conjunction with gamma-glutamyl transpeptidase (GGT) ≥4 times the ULN (an isolated elevation of GGT above 4 times ULN will not exclude the participant).
  • International Normalized Ratio (INR) > 2.7.
  • Inability to provide informed consent: Participants with psychiatric disorders, including hepatic encephalopathy >grade 2, e.g. number connection test >80 seconds.

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, 32806

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BAY 1817080 in Participants With Impaired Hepatic Function (Classified as Child-Pugh A, B or C) in Comparison to Matched Controls With Normal Hepatic 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).

In this study researchers want to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as tablet in participants with mild, moderate or severe hepatic impairment and participants with normal liver function matched for age-, gender-, weight and race.

The study will enroll 36 male and female participants in the age between 18 and 79 years. Participants with mild or moderate hepatic impairment and the matching participants will take multiple oral doses of study drug depending on the study plan. Participants with severe hepatic impairment and the matching participants will take a single oral dose of study drug during the study. Data from this study will provide researcher important information for further development of the study drug in particular on dose recommendation for patients with hepatic impairment.

Being tested
BAY1817080, Midazolam
Keywords
Pharmacokinetics, Safety, Tolerability, Specific population, Subjects with hepatic impairment
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

    Study intervention BAY1817080 will be administered orally with tablet(s).

  • MidazolamDrug

    Midazolam will be administered intravenously with dose of 0.1 mg on Day 1.

Study groups in NCT04454424
Study groupRoleWhat they receive
Arm A: Child-Pugh AExperimentalParticipants with mildly impaired hepatic function (Child-Pugh A)
Receives: Drug: BAY1817080; Drug: Midazolam
Arm B: Child-Pugh BExperimentalParticipants with moderately impaired hepatic function (Child-Pugh B)
Receives: Drug: BAY1817080; Drug: Midazolam
Arm C: Child-Pugh CExperimentalParticipants with severely impaired hepatic function (Child-Pugh C)
Receives: Drug: BAY1817080; Drug: Midazolam
Arm D: Normal hepatic (Matched A and B)ExperimentalParticipants with normal hepatic function matched to Arm A and B
Receives: Drug: BAY1817080; Drug: Midazolam
Arm E: Normal hepatic (Matched to C)ExperimentalParticipants with normal hepatic function matched to Arm C
Receives: Drug: BAY1817080; Drug: Midazolam

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

    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

    AUC (0-12)md,u: Area Under the 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 posted1 Jul 2020
  2. Study start23 Jul 2020
  3. Primary completion24 Jun 2021
  4. Study completion15 Dec 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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454424
Sponsor's protocol ID
20331
Status last verified
Jan 2023
First submitted
29 Jun 2020
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1817080 and Midazolam 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 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 20 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 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 NCT04454424.

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 20 Jan 2023.

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