Clinical PharmacologyPhase 1NCT01473108
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
A Phase 1 study testing Finerenone (BAY 94-8862) PEG solution, Finerenone (BAY 94-8862) immediate release tablet and Eplerenone (Inspra®) in people with Clinical Pharmacology, run by Bayer at 1 site in Germany.
Trial summary
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- Finerenone (BAY 94-8862) PEG solution, Finerenone (BAY 94-8862) immediate release tablet and Eplerenone (Inspra®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2010to 17 May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male white subjects
- 18 to 46 years of age
- Body mass index (BMI): 18 - 29.9 kg/m²
Who cannot join
- Clinically relevant findings in medical history or in the physical examination
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 45 or above 95 beats / min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
Read the detailed description
Clinical pharmacology
- Conditions
- Clinical Pharmacology
- Being tested
- Finerenone (BAY 94-8862) PEG solution, Finerenone (BAY 94-8862) immediate release tablet, Eplerenone (Inspra®), Placebo
- Keywords
- Healthy volunteers, proof-of-concept trial, PK and PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY 94-8862) PEG solutionDrug
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Finerenone (BAY 94-8862) immediate release tabletDrug
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Eplerenone (Inspra®)Drug
Single oral dose of 50 mg eplerenone
PlaceboDrug
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
| Study group | Role | What they receive |
|---|---|---|
| Finerenone (20 mg solution) | Experimental | 3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. Receives: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Placebo |
| Finerenone (10 mg solution) | Experimental | 3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. Receives: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Placebo |
| Finerenone (5 mg solution) | Experimental | 3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. Receives: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Placebo |
| Finerenone (20 mg as tablets) | Experimental | 3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. Receives: Drug: Finerenone (BAY 94-8862) immediate release tablet; Drug: Eplerenone (Inspra®); Drug: Placebo |
| Finerenone (2.5 mg solution) | Experimental | 3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. Receives: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
Measured: Up to 26 hours post-dose
AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
Measured: Up to 60 hours after administration
Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
Measured: Up to 60 hours after administration
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study start29 Mar 2010
- Primary completion30 Nov 2010
- Study completion17 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473108
- Sponsor's protocol ID
- 13786
- Other IDs
- 2010-018500-90
- Status last verified
- Jan 2022
- First submitted
- 18 Aug 2011
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design
- ClinicalTrials.gov ID
- NCT01473108
- Acronym / sponsor ID
- 13786
- Conditions
- Clinical Pharmacology
- Keywords
- Healthy volunteers, proof-of-concept trial, PK and PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2010 (actual)
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 17 May 2011 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
Detailed description
Clinical pharmacology
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Finerenone (20 mg solution) | Experimental | Drug: Finerenone (BAY 94-8862) PEG solution, Drug: Eplerenone (Inspra®), Drug: Placebo3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (10 mg solution) | Experimental | Drug: Finerenone (BAY 94-8862) PEG solution, Drug: Eplerenone (Inspra®), Drug: Placebo3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (5 mg solution) | Experimental | Drug: Finerenone (BAY 94-8862) PEG solution, Drug: Eplerenone (Inspra®), Drug: Placebo3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (20 mg as tablets) | Experimental | Drug: Finerenone (BAY 94-8862) immediate release tablet, Drug: Eplerenone (Inspra®), Drug: Placebo3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (2.5 mg solution) | Experimental | Drug: Finerenone (BAY 94-8862) PEG solution, Drug: Eplerenone (Inspra®), Drug: Placebo3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male white subjects
- 18 to 46 years of age
- Body mass index (BMI): 18 - 29.9 kg/m²
Key exclusion criteria (4 listed)
- Clinically relevant findings in medical history or in the physical examination
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 45 or above 95 beats / min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY 94-8862) PEG solution2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862 | Drug | Finerenone (10 mg solution), Finerenone (2.5 mg solution), Finerenone (20 mg solution), Finerenone (5 mg solution) |
| Finerenone (BAY 94-8862) immediate release tablet20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets | Drug | Finerenone (20 mg as tablets) |
| Eplerenone (Inspra®)Single oral dose of 50 mg eplerenone | Drug | Finerenone (10 mg solution), Finerenone (2.5 mg solution), Finerenone (20 mg as tablets), Finerenone (20 mg solution), Finerenone (5 mg solution) |
| PlaceboMatching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step | Drug | Finerenone (10 mg solution), Finerenone (2.5 mg solution), Finerenone (20 mg as tablets), Finerenone (20 mg solution), Finerenone (5 mg solution) |
Primary outcome
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
Time frame: Up to 26 hours post-dose
AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
Time frame: Up to 60 hours after administration
Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
Time frame: Up to 60 hours after administration
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Finerenone (BAY 94-8862) PEG solution, Finerenone (BAY 94-8862) immediate release tablet and Eplerenone (Inspra®) in people with Clinical Pharmacology, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis) (time frame: Up to 26 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.