Clinical Trials Register

Summary
EudraCT Number:	2016-002813-24
Sponsor's Protocol Code Number:	BAY94-8862/16538
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-09-23
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2016-002813-24

A.3

Full title of the trial

Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushed tablet (adult formulation) in the fasting condition, and to investigate the effect of a high fat, high calorie meal on the suspension in healthy male subjects in a randomized, open-label, four-fold crossover design

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Phase I relative bioavailability and food effect study

A.4.1

Sponsor's protocol code number

BAY94-8862/16538

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/025/2015

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bayer AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49 30 300139003
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 94-8862 Oral suspension
D.3.2	Product code	BAY 94-8862 Oral suspension
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862 micronized
D.3.9.3	Other descriptive name	BAY 94-8862
D.3.9.4	EV Substance Code	SUB30924
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3,4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 94-8862 IR tablet 20 mg
D.3.2	Product code	BAY 94-8862 coated tablet 20 mg
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862 micronized
D.3.9.3	Other descriptive name	BAY 94-8862
D.3.9.4	EV Substance Code	SUB30924
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetic kidney disease

E.1.1.1

Medical condition in easily understood language

Treatment of patients with diabetic kidney disease

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objectives of this study are to
•investigate the relative bioavailability of a single oral dose of 20 mg finerenone suspension and 20 mg crushed and resuspended tablet in comparison to 20 mg finerenone tablet in the fasting condition
•investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 20 mg finerenone suspension
•investigate whether 20 mg finerenone suspension and 20 mg crushed and resuspended tablet are palatable and swallowable

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to
•investigate the safety and tolerability of single oral doses of finerenone

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.The informed consent must be signed before any study specific tests or procedures are done
2.Healthy male subject
3.Age: 18 to 45 years (inclusive) at the first screening examination/visit
4.Race: White
5.Body mass index (BMI): ≥18 and ≤29.9 kg/ m²
6.Ability to understand and follow study-related instructions
7.Confirmation of the subject’s health insurance coverage prior to the first screening examination/ visit
8.Male subjects with a female partner of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condom or diaphragm or cervical cap with hormonal contraception, condom or diaphragm or cervical cap with an intrauterine device). This applies for the time period between signing of the informed consent form and 1 week after the last administration of study drug

E.4

Principal exclusion criteria

Medical and surgical history

1.Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
2.A history of relevant diseases of vital organs, of the central nervous system or other organs
3.Known renal or liver insufficiency
4.Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
5.Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator
6.Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
7.Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
8.Known hypersensitivity to components of the American breakfast
9.Known severe allergies, non-allergic drug reactions, or multiple drug allergies
10.Relevant diseases within the last 4 weeks prior to the first study drug administration
11.Febrile illness within 1 week before the first study drug administration

Medication, drug use and special behavioral patterns

12.Regular use of medicines
13.Use of prohibited medicines/substances (e.g. CYP3A4 inducers, CYP3A4 inhibitors) within 2 weeks before the first study drug administration
14.Regular use of therapeutic or recreational drugs, e.g. carnitine products, anabolics, high dose vitamins
15.Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
16.Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
17.Suspicion of drug or alcohol abuse
18.Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it
19.Regular daily consumption of more than 1 L of xanthine-containing beverages
20.Intake of foods or beverages containing grapefruit, pomelo, or Seville oranges within 2 weeks before the first study drug administration until follow-up
21.Intake of St John’s Wort within 2 weeks before the first study drug administration until follow-up
22.Donation of more than 100 mL of blood within 4 weeks before the first study drug administration
23.Donation of more than 500 mL of blood within 3 months before the first study drug administration
24.Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment

Electrocardiogram (ECG), blood pressure, heart rate

25.Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the QTcB-interval over 450 msec
26.Systolic blood pressure below 100 or above 140 mmHg
27.Diastolic blood pressure below 60 or above 90 mmHg
28.Heart rate below 50 or above 90 beats/ min

Physical examination

29.Clinically relevant findings in the physical examination

Laboratory examination

30.Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immunodeficiency virus antibodies (anti-HIV 1+2)
31.Positive urine drug screening
32.Positive alcohol breath test
33.Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, clotting status, or urinalysis from reference ranges

E.5 End points

E.5.1

Primary end point(s)

AUC* and Cmax of finerenone

* AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC

E.5.1.1

Timepoint(s) of evaluation of this end point

Blood sampling for finerenone will be performed from pre-dose up to 24 hours after drug administration in each treatment period

E.5.2

Secondary end point(s)

N/A

E.5.2.1

Timepoint(s) of evaluation of this end point

N/A

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Phase I study in healthy male subjects

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Single-center, randomized, open-label, four-fold crossover design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the study as a whole will be the date when the clean database is available.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the end of this study, further treatment is not necessary since only healthy subjects will be included in the study.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-11-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-03-01

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