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

Pharmacology, Clinical Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04322253
• Other study ID #: 15139
• Secondary ID: 2017-000482-74
• Status: Terminated
• Phase: Phase 1
• Start date: August 24, 2017
• Est. completion date: December 17, 2018

Study information

• Verified date: March 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 17, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pharmacology, Clinical

Intervention

Drug:
• Neladenoson bialanate (BAY 1067197)
10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fu for BAY 84-3174	Fraction of free (unbound) drug in plasma or serum after single dose administration	At 4 hours after study drug administration
Primary	AUC for BAY 84-3174	Area under the concentration vs. time curve from zero to infinity after single dose administration	Pre-dose up to 49 days after study drug administration
Primary	AUCu for BAY 84-3174	AUC of unbound drug after single dose administration	Pre-dose up to 49 days after study drug administration
Primary	AUCnorm for BAY 84-3174	AUC divided by dose per body weight after single dose administration	Pre-dose up to 49 days after study drug administration
Primary	Cmax for BAY 84-3174	Maximum observed drug concentration in measured matrix after single dose administration	Pre-dose up to 49 days after study drug administration
Primary	Cmax,u for BAY 84-3174	Cmax of unbound drug after single dose administration	Pre-dose up to 49 days after study drug administration
Primary	Cmax,norm for BAY 84-3174	Cmax divided by dose per body weight after single dose administration	Pre-dose up to 49 days after study drug administration
Secondary	Number of subjects with treatment-emergent adverse events (TEAEs)		Up to 49 days after study drug administration

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