Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects

NCT03145038 | Completed Phase 1

• 2 other identifiers: 185812016-005074-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  0 - 72 hours

Secondary Outcomes (2)

• Number of Adverse Events

  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

  up to 5 minutes after drug administration

Study Arms (6)

Treatment A

EXPERIMENTAL

Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast

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

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

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

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

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

Drug: Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast

Interventions

Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed DRUG

Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets

Treatment A

Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted DRUG

Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets

Treatment B

Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed DRUG

Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets

Treatment C

Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast DRUG

10 mg IR tablet, intact (fed; American breakfast)

Treatment D

Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast DRUG

10 mg IR tablet, crushed (fed; American breakfast)

Treatment E

Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast DRUG

10 mg IR tablet, intact (fed; Continental breakfast)

Treatment F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products.

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 16, 2017
• Primary Completion: August 29, 2017
• Study Completion: October 9, 2017
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

DE (1)