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 of 10 mg Immediate Release Tablet in Participants With Renal 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). Renal impairment which co-occurs in...
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 re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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:
- 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
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04320771
Start Date
November 2 2017
End Date
December 17 2018
Last Update
March 26 2020
Active Locations (2)
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1
APEX GmbH
München, Bavaria, Germany, 81241
2
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany, 24105