PharmacokineticsPhase 1NCT02957396
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
A Phase 1 study testing Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet and Finerenone (BAY94-8862): 20 mg suspension in people with Pharmacokinetics, run by Bayer at 1 site in Germany.
Trial summary
Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet and Finerenone (BAY94-8862): 20 mg suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2016to 1 Mar 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Age: 18 to 45 years (inclusive)
- Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
- Race: White
Who cannot join
- Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
- A history of relevant diseases of vital organs, of the central nervous system or other organs
- Known renal or liver insufficiency
- 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)
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator
- 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
Show all 9Show fewer
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.
- Conditions
- Pharmacokinetics
- Being tested
- Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet, Finerenone (BAY94-8862): 20 mg suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862): 20 mg intact tabletDrug
20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg crushed and resuspended tabletDrug
20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg suspensionDrug
20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
| Study group | Role | What they receive |
|---|---|---|
| Adult formulation: Finerenone tablet_Fasting | Active comparator | Single oral dose of 20 mg intact finerenone tablet fasting Receives: Drug: Finerenone (BAY94-8862): 20 mg intact tablet |
| Adult formulation: Finerenone crushed tablet_Fasting | Experimental | Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting Receives: Drug: Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet |
| Pediatric formulation: Finerenone suspension_Fasting | Experimental | Single oral dose of 20 mg finerenone suspension fasting Receives: Drug: Finerenone (BAY94-8862): 20 mg suspension |
| Pediatric formulation: Finerenone suspension_Fed | Experimental | Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast Receives: Drug: Finerenone (BAY94-8862): 20 mg suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finerenone area under the plasma concentration vs. time curve (AUC)
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Finerenone maximum plasma concentration (Cmax)
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Appearance of oro-dispersible tablets assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Taste of oro-dispersible tablets assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Texture of oro-dispersible tablets assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Smell of oro-dispersible tablets assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Overall impression of oro-dispersible tablets assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
Measured: Up to 5 minutes after drug administration
Secondary outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start17 Nov 2016
- Primary completion13 Jan 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957396
- Sponsor's protocol ID
- 16538
- Other IDs
- 2016-002813-24, 2016
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02957396
- Acronym / sponsor ID
- 16538
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 7 Nov 2016 (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.
Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult formulation: Finerenone tablet_Fasting | Active comparator | Drug: Finerenone (BAY94-8862): 20 mg intact tabletSingle oral dose of 20 mg intact finerenone tablet fasting |
| Adult formulation: Finerenone crushed tablet_Fasting | Experimental | Drug: Finerenone (BAY94-8862): 20 mg crushed and resuspended tabletSingle oral dose of 20 mg crushed and resuspended finerenone tablet fasting |
| Pediatric formulation: Finerenone suspension_Fasting | Experimental | Drug: Finerenone (BAY94-8862): 20 mg suspensionSingle oral dose of 20 mg finerenone suspension fasting |
| Pediatric formulation: Finerenone suspension_Fed | Experimental | Drug: Finerenone (BAY94-8862): 20 mg suspensionSingle oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects
- Age: 18 to 45 years (inclusive)
- Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
- Race: White
Key exclusion criteria (9 listed)
- Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
- A history of relevant diseases of vital organs, of the central nervous system or other organs
- Known renal or liver insufficiency
- 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)
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator
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 (BAY94-8862): 20 mg intact tablet20 mg intact finerenone immediate-release tablet; single dose in the fasting condition | Drug | Adult formulation: Finerenone tablet_Fasting |
| Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition | Drug | Adult formulation: Finerenone crushed tablet_Fasting |
| Finerenone (BAY94-8862): 20 mg suspension20 mg finerenone suspension; single dose in the fasting condition or in the fed condition | Drug | Pediatric formulation: Finerenone suspension_Fasting, Pediatric formulation: Finerenone suspension_Fed |
Primary outcome
Finerenone area under the plasma concentration vs. time curve (AUC)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Finerenone maximum plasma concentration (Cmax)
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Appearance of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Taste of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Texture of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Smell of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Overall impression of oro-dispersible tablets assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
Time frame: Up to 5 minutes after drug administration
1 secondary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 4 weeks
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 24 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet and Finerenone (BAY94-8862): 20 mg suspension in people with Pharmacokinetics, 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 4 inclusion and 9 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 24 Apr 2017. 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?
Finerenone area under the plasma concentration vs. time curve (AUC) (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours). The study lists 8 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 24 Apr 2017.