Terminated/Withdrawn

Pharmacology, Clinical

Bayer Identifier:

15139

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2017-000482-74

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Inclusion Criteria
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.
Exclusion Criteria
- 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:
- 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 summary

Enrollment Goal

Trial Dates

August 2017 - December 2018

Phase

Phase 1

Could I Receive a placebo

Products

Neladenoson Bialanate (BAY1067197)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Kiel GmbH	Kiel, 24105, Germany

Primary Outcome

fu for BAY 84-3174
Fraction of free (unbound) drug in plasma or serum after single dose administration
Time Frame:
At 4 hours after study drug administration
AUC for BAY 84-3174
Area under the concentration vs. time curve from zero to infinity after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration
AUCu for BAY 84-3174
AUC of unbound drug after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration
AUCnorm for BAY 84-3174
AUC divided by dose per body weight after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration
Cmax for BAY 84-3174
Maximum observed drug concentration in measured matrix after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration
Cmax,u for BAY 84-3174
Cmax of unbound drug after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration
Cmax,norm for BAY 84-3174
Cmax divided by dose per body weight after single dose administration
Time Frame:
Pre-dose up to 49 days after study drug administration

Secondary Outcome

Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame:
Up to 49 days after study drug administration

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Non-randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find results for studies related to Bayer products