Terminated/Withdrawn

Pharmacology, Clinical

Bayer Identifier:

15138

ClinicalTrials.gov Identifier:

NCT04320771

EudraCT Number:

2017-000795-28

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 of 10 mg immediate release tablet in participants with renal 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). 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

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Inclusion Criteria
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 Criteria
- 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

Trial summary

Enrollment Goal

Trial Dates

November 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
Completed	APEX GmbH	München, 81241, Germany
Withdrawn	SocraTec R&D Clinical Ward	Erfurt, 99084, Germany

Primary Outcome

Cmax for BAY 84-3174
Maximum observed drug concentration in measured matrix after single dose administration
Time Frame:
Pre-dose up to approximately 6 weeks after dosing
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 approximately 6 weeks after dosing
Cmax,norm for BAY 84-3174
Cmax divided by dose per body weight after single dose administration
Time Frame:
Pre-dose up to approximately 6 weeks after dosing
AUCnorm for BAY 84-3174
AUC divided by dose per body weight after single dose administration
Time Frame:
Pre-dose up to approximately 6 weeks after dosing
Cmax,u for BAY 84-3174
Cmax of unbound drug after single dose administration
Time Frame:
Pre-dose up to approximately 6 weeks after dosing
AUCu for BAY 84-3174
AUC of unbound drug after single dose administration
Time Frame:
Pre-dose up to approximately 6 weeks after dosing
fu for BAY 84-3174
Fraction of free (unbound) drug in plasma or serum after single dose administration
Time Frame:
At 4 hours after dosing

Secondary Outcome

Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame:
Up to approximately 6 weeks after dosing

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Non-randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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