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AzTrials

Pharmacology, ClinicalPhase 1NCT04320771

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 of 10 mg Immediate Release Tablet in Participants With Renal 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 2 sites 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). Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they… 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
18 participants
Where
2 sitesGermany
Study dates
2 Nov 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 or female White subjects (women without childbearing potential), aged 18 to 79 years (inclusive), body mass index 18 to 34 kg/m² (both inclusive)
  • Subjects with renal impairment:
  • Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m² determined from serum creatinine 2-14 days prior to dosing using the Modification of Diet in Renal Disease equation
  • Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit.
  • Healthy subjects:
  • Age-, weight- and gender matched healthy subjects

Who cannot join

  • An anatomical abnormality of the gut (e.g. gut surgery, continent ileostomy) that could affect the retention times of the drug in the stomach/gut adversely
  • Gastric vagotomy or other condition that might adversely affect the gastric pH level
  • Pancreatic dysfunction/insufficiency
  • Febrile illness within 1 week prior to admission to study center
  • Use of the following co-medications
  • From 2 weeks before administration until end of follow-up:
Show all 18Show fewer
  • Cytochrome P450 (CYP)3A4 inhibitors (Of note: grapefruit is a strong CYP3A4 inhibitor)
  • CYP3A4 inducers
  • CYP2C8 inhibitors (Of note: clopidogrel is a strong CYP2C8 inhibitor)
  • Theophylline
  • On the day of dosing with neladenoson bialanate:
  • Drugs that undergo significant systemic metabolism over gut wall uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) substrates (e.g. irinotecan)
  • Major breast cancer resistance protein (BCRP) substrates
  • Regular daily consumption of more than 1 L - Plasmapheresis within 4 weeks before study drug administration
  • Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration
  • History of relevant and not cured cardiac rhythm disorders (i.e. Wolff-Parkinson-White syndrome, intermittent second- or third-degree AV block)
  • Positive urine drug screening
  • Subjects tested to be positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • CRS Clinical-Research-Services Kiel GmbH

    Kiel, Schleswig-Holstein, 24105

  • APEX GmbH

    München, Bavaria, 81241

Other trials in Germany

About this study

Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Neladenoson Bialanate in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects Following a Single Oral Dose of 10 mg Neladenoson Bialanate Given as IR Tablet in a Single-center, Nonrandomized, Non-controlled, Non-blinded, Study With Group Stratification

Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood 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 of 10 mg immediate release tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight

Read the detailed description

Study was originally designed with 4 arms (normal renal function, mild, moderate, and severe renal impairment), however as the study was prematurely terminated, there was no participant with normal renal function enrolled

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 NCT04320771
Study groupRoleWhat they receive
Neladenoson bialanate, mild renal impairmentExperimentalSubjects with eGFR ≥60 - <90 mL/min/1.73 received a single immediate-release (IR) tablet dose of 10 mg of neladenoson bialanate in the fasted state
Receives: Drug: Neladenoson bialanate (BAY 1067197)
Neladenoson bialanate, moderate renal impairmentExperimentalSubjects with eGFR ≥30 - <60 mL/min/1.73 received a single IR tablet dose of 10 mg of neladenoson bialanate in the fasted state
Receives: Drug: Neladenoson bialanate (BAY 1067197)
Neladenoson bialanate, severe renal impairmentExperimentalSubjects with eGFR <30 mL/min/1.73 received a single IR tablet dose of 10 mg of 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. Cmax for BAY 84-3174

    Maximum observed drug concentration in measured matrix after single dose administration

    Measured: Pre-dose up to approximately 6 weeks after dosing

  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 approximately 6 weeks after dosing

  3. Cmax,norm for BAY 84-3174

    Cmax divided by dose per body weight after single dose administration

    Measured: Pre-dose up to approximately 6 weeks after dosing

  4. AUCnorm for BAY 84-3174

    AUC divided by dose per body weight after single dose administration

    Measured: Pre-dose up to approximately 6 weeks after dosing

  5. Cmax,u for BAY 84-3174

    Cmax of unbound drug after single dose administration

    Measured: Pre-dose up to approximately 6 weeks after dosing

  6. AUCu for BAY 84-3174

    AUC of unbound drug after single dose administration

    Measured: Pre-dose up to approximately 6 weeks after dosing

  7. fu for BAY 84-3174

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

    Measured: At 4 hours after dosing

Secondary outcomes (1)

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

    Measured: Up to approximately 6 weeks after dosing

Timeline

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

  1. First posted25 Mar 2020
  2. Study start2 Nov 2017
  3. Primary completion8 Aug 2018
  4. Study completion17 Dec 2018

Why it stopped: Termination 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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320771
Sponsor's protocol ID
15138
Other IDs
2017-000795-28, 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 2 sites 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 7 inclusion and 18 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 2 sites 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: Termination 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?

Cmax for BAY 84-3174 (time frame: Pre-dose up to approximately 6 weeks after dosing). 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 NCT04320771.

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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