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AzTrials

Pharmacology, ClinicalPhase 1NCT04322253

Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

A Phase 1 study testing Neladenoson bialanate (BAY 1067197) in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Liver impairment is a condition in which the liver is not working as well as they should. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacology, Clinical
What is being tested?
Neladenoson bialanate (BAY 1067197)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteGermany
Study dates
24 Aug 2017to 17 Dec 2018
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

  • All subjects
  • Male and female Caucasian subjects between 18 and 79 years of age (both inclusive) with a body mass index above/equal 18.0 and below/equal 34.0 kg/m² Subjects with hepatic impairment
  • Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
  • Subjects with hepatic impairment as per Child Pugh system
  • Subjects with stable liver disease during the last 2 months Healthy subjects
  • Healthy subjects with mean age and body weight not varying by more than ±10 years and ±10 kg from the groups of subjects with mild and moderate hepatic impairment, respectively.

Who cannot join

  • Medical history of continent ileostomy.
  • Febrile illness within 1 week prior to admission to study center.
  • Known hypersensitivity to the study drug (active substances or excipients of the preparation).
  • Subjects with diagnosed malignancy within the past 5 years.
  • Use of any systemic or topical medicine or substances which oppose the study objectives or which might influence them, in particular:
  • Starting from screening on, but minimum from 2 weeks before the study drug administration until the follow-up visit:
Show all 17Show fewer
  • CYP3A4 inducers
  • CYP3A4 inhibitors
  • Potent CYP2C8 inhibitors
  • Major uridine diphosphate-glucuronosyltransferase isoenzyme 1A1 (UGT1A1) substrate (irinotecan)
  • On the day of administration of neladenoson bialanate:
  • Major breast cancer resistance protein (BCRP) substrates
  • Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of of more than 2 units of alcohol in another form - Intake of ethanol containing food and beverages from 48 h prior to admission to the study center until 96 h after study drug administration, afterwards not more than 2 units of alcohol per day until follow-up examination.
  • Intake of food and beverages containing grapefruit or pomelo from 14 days prior to study drug administration up to the last time point of PK sampling.
  • Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
  • Positive urine drug screening.
  • Positive results for human immune deficiency - Abnormal (clinically significant) thyroid stimulating hormone (TSH).

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical-Research-Services Kiel GmbH

    Kiel, Schleswig-Holstein, 24105

Other trials in Germany

About this study

Official title: Investigation of the Pharmacokinetics, Safety, and Tolerability of Neladenoson Bialanate in Subjects With Hepatic Impairment (Classified as Child Pugh A and B) and in Age-, Weight-, and Gender-matched Healthy Subjects, Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded Study

Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Liver impairment is a condition in which the liver is not working as well as they should. The goal of the study is to learn more about the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and excretes the study dug given as a single oral dose neladenoson bialanate in participants with liver impairment and healthy participants matched for age-, gender-, and weight

Being tested
Neladenoson bialanate (BAY 1067197)

What participants receive

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

  • Neladenoson bialanate (BAY 1067197)Drug

    10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Study groups in NCT04322253
Study groupRoleWhat they receive
Neladenoson bialanate, mild hepatic impairmentExperimentalSubjects with Child Pugh score 5 or 6 received a single immediate-release (IR) tablet dose of 10 mg neladenoson bialanate in the fasted state
Receives: Drug: Neladenoson bialanate (BAY 1067197)
Neladenoson bialanate, moderate hepatic impairmentExperimentalSubjects with Child Pugh score 7-9 received a single IR tablet dose of 10 mg neladenoson bialanate in the fasted state
Receives: Drug: Neladenoson bialanate (BAY 1067197)
Neladenoson bialanate, control groupExperimentalHealthy subjects matched for age, gender and body weight received a single IR tablet dose of 10 mg neladenoson bialanate in the fasted state
Receives: Drug: Neladenoson bialanate (BAY 1067197)

What is being measured

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

  1. fu for BAY 84-3174

    Fraction of free (unbound) drug in plasma or serum after single dose administration

    Measured: At 4 hours after study drug administration

  2. AUC for BAY 84-3174

    Area under the concentration vs. time curve from zero to infinity after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

  3. AUCu for BAY 84-3174

    AUC of unbound drug after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

  4. AUCnorm for BAY 84-3174

    AUC divided by dose per body weight after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

  5. Cmax for BAY 84-3174

    Maximum observed drug concentration in measured matrix after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

  6. Cmax,u for BAY 84-3174

    Cmax of unbound drug after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

  7. Cmax,norm for BAY 84-3174

    Cmax divided by dose per body weight after single dose administration

    Measured: Pre-dose up to 49 days after study drug administration

Secondary outcomes (1)

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

    Measured: Up to 49 days after study drug administration

Timeline

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

  1. First posted26 Mar 2020
  2. Study start24 Aug 2017
  3. Primary completion22 Aug 2018
  4. Study completion17 Dec 2018

Why it stopped: The cessation of the development project for neladenoson bialanate.

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322253
Sponsor's protocol ID
15139
Other IDs
2017-000482-74, 2017
Status last verified
Mar 2020
First submitted
23 Mar 2020
Last updated
26 Mar 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neladenoson bialanate (BAY 1067197) in people with Pharmacology, Clinical, 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 26 Mar 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 was stopped early (reason given: The cessation of the development project for neladenoson bialanate.). Results are not available in the source record.

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?

fu for BAY 84-3174 (time frame: At 4 hours after study drug administration). The study lists 7 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 NCT04322253.

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 2020.

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