Status:
TERMINATED
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
Lead Sponsor:
Bayer
Conditions:
Pharmacology, Clinical
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04322253
Start Date
August 24 2017
End Date
December 17 2018
Last Update
March 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany, 24105