PharmacokineticsPhase 1NCT03145038
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
A Phase 1 study testing Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed, Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted and Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed in people with Pharmacokinetics, run by Bayer at 1 site in Germany.
Trial summary
Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). 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?
- Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed, Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted and Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 16 May 2017to 9 Oct 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 subject
- Age: 18 to 45 years (inclusive) at informed consent
- Race: white
- Body Mass Index (BMI): above or equal 18.0 and below or equal 29.9 kg / m²
Who cannot join
- 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
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Febrile illness within 1 week prior to the first study drug administration
- History of postural syncopes
- A history of relevant diseases of vital organs, of the central nervous system or other organs
Show all 10Show fewer
- A history of relevant smell and / or taste disorders
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
- Known gastro-intestinal disorders (e.g. stomach ulcers, duodenal ulcers, gastrointestinal bleeding) or inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061
About this study
Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.
- Conditions
- Pharmacokinetics
- Being tested
- Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed, Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted, Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed, Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast, Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat(BAY1021189, high-dose pediatric-formulation)_fedDrug
Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets
Vericiguat(BAY1021189, high-dose pediatric-formulation)_fastedDrug
Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets
Vericiguat(BAY1021189, low-dose pediatric-formulation)_fedDrug
Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets
Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfastDrug
10 mg IR tablet, intact (fed; American breakfast)
Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfastDrug
10 mg IR tablet, crushed (fed; American breakfast)
Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfastDrug
10 mg IR tablet, intact (fed; Continental breakfast)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast Receives: Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed |
| Treatment B | Experimental | Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted Receives: Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted |
| Treatment C | Experimental | Single oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast Receives: Drug: Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed |
| Treatment D | Active comparator | Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast Receives: Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast |
| Treatment E | Experimental | Single oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast Receives: Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast |
| Treatment F | Experimental | Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, continental breakfast Receives: Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)
AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of vericiguat after single dose administration in blood plasma against time (pre-dose until 72 hours after administration). AUC from time 0 to the last data point greater than lower limit of quantification divided by dose (AUC(0-tlast)/D) will be used as primary parameter if AUC cannot be calculated for all profiles, or mean AUC from the last data point to infinity [AUC(tlast-∞)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.
Measured: 0 - 72 hours
Vericiguat maximum plasma concentration divided by dose (Cmax/D))
Cmax is the maximum observed vericiguat concentration in measured plasma after single dose administration (pre-dose until 72 hours after administration). Cmax/D is the maximum observed drug concentration in measured matrix after single dose administration divided by dose.Cmax will be analyzed by means of descriptive statistics
Measured: 0 - 72 hours
Secondary outcomes (2)
Number of Adverse Events
As a secondary objective of this study the numbers of AEs will be used to assess safety and tolerability of vericiguat.
In a clinical study, an AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Individual listings of AEs will be provided. The incidence of treatment-emergent AEs an drug-related AEs, respectively, will be summarized by treatment using MedDRA terms (highly specific standardised medical terminology).
Measured: pre-dose until 7 to 14 days after last administration of vericiguat
Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire
As a secondary objective of this study the taste and texture of pediatric formulation (palatability) (mini tablets) and of the crushed IR tablet will be assessed
Measured: up to 5 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start16 May 2017
- Primary completion29 Aug 2017
- Study completion9 Oct 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03145038
- Sponsor's protocol ID
- 18581
- Other IDs
- 2016-005074-35, 2016
- Status last verified
- Dec 2021
- First submitted
- 5 May 2017
- Last updated
- 29 Dec 2021
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT03145038
- Acronym / sponsor ID
- 18581
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 May 2017 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fedSingle oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast |
| Treatment B | Experimental | Drug: Vericiguat(BAY1021189, high-dose pediatric-formulation)_fastedSingle oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted |
| Treatment C | Experimental | Drug: Vericiguat(BAY1021189, low-dose pediatric-formulation)_fedSingle oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast |
| Treatment D | Active comparator | Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfastSingle oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast |
| Treatment E | Experimental | Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfastSingle oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast |
| Treatment F | Experimental | Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfastSingle oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, continental 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 subject
- Age: 18 to 45 years (inclusive) at informed consent
- Race: white
- Body Mass Index (BMI): above or equal 18.0 and below or equal 29.9 kg / m²
Key exclusion criteria (10 listed)
- 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
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Febrile illness within 1 week prior to the first study drug administration
- History of postural syncopes
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 |
|---|---|---|
| Vericiguat(BAY1021189, high-dose pediatric-formulation)_fedVericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets | Drug | Treatment A |
| Vericiguat(BAY1021189, high-dose pediatric-formulation)_fastedVericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets | Drug | Treatment B |
| Vericiguat(BAY1021189, low-dose pediatric-formulation)_fedVericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets | Drug | Treatment C |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast10 mg IR tablet, intact (fed; American breakfast) | Drug | Treatment D |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast10 mg IR tablet, crushed (fed; American breakfast) | Drug | Treatment E |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast10 mg IR tablet, intact (fed; Continental breakfast) | Drug | Treatment F |
Primary outcome
Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D)
Time frame: 0 - 72 hours
AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of vericiguat after single dose administration in blood plasma against time (pre-dose until 72 hours after administration). AUC from time 0 to the last data point greater than lower limit of quantification divided by dose (AUC(0-tlast)/D) will be used as primary parameter if AUC cannot be calculated for all profiles, or mean AUC from the last data point to infinity [AUC(tlast-∞)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.
Vericiguat maximum plasma concentration divided by dose (Cmax/D))
Time frame: 0 - 72 hours
Cmax is the maximum observed vericiguat concentration in measured plasma after single dose administration (pre-dose until 72 hours after administration). Cmax/D is the maximum observed drug concentration in measured matrix after single dose administration divided by dose.Cmax will be analyzed by means of descriptive statistics
2 secondary outcomes
Number of Adverse Events
Time frame: pre-dose until 7 to 14 days after last administration of vericiguat
Palatability of the oro-dispersible tablets and the crushed IR tablets assessed by questionnaire
Time frame: up to 5 minutes after drug administration
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 29 Dec 2021.
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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 Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed, Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted and Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed 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 10 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 29 Dec 2021. 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?
Vericiguat area under the plasma concentration vs. time curve divided by dose (AUC/D) (time frame: 0 - 72 hours). The study lists 2 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 29 Dec 2021.