Study Completed

Clinical pharmacology

Bayer Identifier:

15356

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-004841-42

EU CT Number:

Not Available

Relative bioavailability and food interaction study of BAY1021189

Trial purpose

Primary objectives:
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
Secondary objectives:
- Safety, tolerability and pharmacodynamics of BAY 1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

Inclusion Criteria
- Healthy white male volunteers, age 18-45 years, body mass index: ≥ 18 and ≤ 29.9 kg/m²
Exclusion Criteria
- Recent donation of blood/blood components
- Clinically relevant changes/deviations from normal ECG, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs)
- Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, foods or beverages containing grapefruit and/or cigarettes that may affect study results
- Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies or with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
- Regular use of therapeutic or recreational drugs
- Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- Subjects testing positive in the drug screening
- Incompletely cured pre-existing diseases for which it could be assumed that
the absorption, distribution, metabolism, elimination and effects of the study
drugs were not be normal
- Subject testing positive for human immunodeficiency virus type 1 and 2 antibody, hepatitis B surface antigen or hepatitis C virus antibody
- Special diets preventing the subjects from eating the standard meals during the study
- History of postural syncopes

Trial summary

Enrollment Goal

Trial Dates

December 2011 - June 2012

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Wuppertal, 42113, Germany

Primary Outcome

Number of participants with adverse events
Time Frame:
Approximately 8 weeks
Safety Issue:
Yes
BP
Blood pressure
Time Frame:
Approximately 8 weeks
Safety Issue:
Yes
HR over 1 min
Heart rate over 1 min
Time Frame:
Pre-dose and up to 24 h post-dose
Safety Issue:
No
Plasma cGMP
Plasma cyclic guanosine monophosphate
Time Frame:
Pre-dose and up to 24 h post-dose
Safety Issue:
No
Impedance cardiography
The following variables were measured: stroke volume, cardiac output, heart rate, cardiac index
Time Frame:
Pre-dose and up to 8 h post-dose
Safety Issue:
No
HR
Heart rate
Time Frame:
Approximately 8 weeks
Safety Issue:
Yes
AUC
Area under the plasma concentration vs time curve from zero to infinity after single dose
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
AUC/D
AUC divided by dose (mg)
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
Cmax/D
Maximum drug concentration in plasma after single dose administration divided by dose (mg)
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
Cmax
Maximum drug concentration in plasma after single dose administration
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No

Secondary Outcome

AUCnorm
Area under the curve divided by dose per kg body weight
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
Cmax,norm
Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
tmax
Time to reach maximum drug concentration in plasma after single dose
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
t½
Half-life associated with the terminal slope
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
CL/F
Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No
Vz/F
Apparent volume of distribution during terminal phase after oral administration
Time Frame:
From pre-dose up to 72 h post-dose
Safety Issue:
No

Trial design

Relative bioavailability study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of 1.25 mg and 5 mg BAY 1021189 IR tablets in comparison to 5 mg oral solution, and to investigate the influence of a high fat, high calorie meal on the 5 mg IR tablet in 16 healthy male subjects in a single dose, randomized, open-label, four-fold cross-over design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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