Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
60
Countries
1
Sites
1
Heart failure with left ventricular ejection fraction ≥40%
To assess the bioequivalence between finerenone 2 x 20 mg tablets and 1 x 40 mg tablet
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 27 Apr 2023 → 28 Jul 2023
- Decision date (initial)
- 2023-03-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bayer AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Bioequivalence
To assess the bioequivalence between finerenone 2 x 20 mg tablets and 1 x 40 mg tablet
Secondary objectives 1
- To monitor safety and the tolerability of finerenone tablets
Conditions and MedDRA coding
Heart failure with left ventricular ejection fraction ≥40%
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10078289 | Heart failure with reduced ejection fraction | 10007541 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study This bioequivalence study will be conducted in a single center, randomized, non-blinded, two-way crossover design. The bioequivalence between finerenone 2 x 20 mg tablets and 1 x 40 mg tablet will be assessed.
|
Randomised Controlled | None | finerenone sequences: 1 x 40 mg_2 x 20 mg: Subjects will receive a single oral dose of 40 mg (1 x 40 mg tablet) finerenone first, with a washout period of at least 72 hours, subjects will then receive another single oral dose of 40 mg (2 x 20 mg tablets) finerenone finerenone sequences: 2 x 20 mg _1 x 40 mg: Subjects will receive a single oral dose of 40 mg (2 x 20 mg tablets) finerenone first, with a washout period of at least 72 hours, subjects will then receive another single oral dose of 40 mg (1 x 40 mg tablet) finerenone |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, body temperature, vital signs, and ECG.
- BMI within the range 18.0 to 29.9 kg/m2 (inclusive) at the screening visit.
- Contraceptive use by men and female partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria 6
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g., non-investigational medicinal products, challenge agents, or rescue medication.
- Participant with thyroid disorders as evidenced by assessment of thyroid stimulating hormone level outside the normal reference range at the screening visit.
- Medical disorder, condition or history of such that would impair the participant’s ability to take part in or complete this study in the opinion of the investigator.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Use of systemic or topical medicines or substances which might influence the study objectives.
- Suspicion of drug or alcohol abuse.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Cmax for plasma finerenone concentration
- AUC(0-tlast) for plasma finerenone concentration
Secondary endpoints 1
- Number of subjects with treatment-emergent adverse events (TEAEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD1624191 · Product
- Active substance
- Finerenone
- Substance synonyms
- BAY 94-8862
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD9408174 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| CRS Clinical Research Services Management GmbH ORG-100039537
|
Wuppertal, Germany | Code 11, Code 5 |
| ClinAssess Gesellschaft fuer Klinische Forschung mbH ORG-100009848
|
Leverkusen, Germany | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-04-27 | 2023-07-28 | 2023-05-02 | 2023-07-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results_EN_2022-502385-24-00 SUM-33854
|
2024-07-19T14:16:36 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson summary of Results_EN_2022-502385-24-00 | 2024-07-19T14:16:50 | Submitted | Laypersons Summary of Results |
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | Clinical_Study_Report_Document_s_Public_2022-502385-24-00_EN | 1 |
| Clinical study report (for publication) | CSR_Appendix_10_1_1_Public_2022-502385-24-00_EN | 1 |
| Clinical study report (for publication) | CSR_Appendix_10_1_2_Public_2022-502385-24-00_EN | 1 |
| Clinical study report (for publication) | CSR_Appendix_10_1_9_Public_2022-502385-24-00_EN | 1 |
| Laypersons summary of results (for publication) | Layperson summary of Results_EN_2022-502385-24-00 | 1 |
| Summary of results (for publication) | Summary of Results_EN_2022-502385-24-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-09 | Germany | Acceptable 2023-03-28
|
2023-03-30 |