Study Completed

Clinical pharmacology

Bayer Identifier:

15811

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000932-25

EU CT Number:

Not Available

BAY1021189, Omeprazol/Antacida Interaction Study

Trial purpose

Primary objective:
To investigate the influence of a co-administration of a single dose of 10 mL Maalox® 70 mVal Suspension and a 4 day pre- and one time co-treatment of 2 x 20 mg Antra® once daily on the pharmacokinetics of 5 mg BAY 1021189 in comparison to 5 mg BAY 1021189 alone, both given orally as 4 x 1.25 mg immediate release tablets, in a three-fold crossover, randomized, open label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

Inclusion Criteria
- Healthy, white male subjects, 18 to 45 years of age, body mass index: between ≥18.0 and ≤29.9 kg/m2
Exclusion Criteria
- 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
- Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal
- 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 testing positive in the drug screening
- Positive urine drug screening
- Special diets preventing the subjects from eating the standard meals during the study

Trial summary

Enrollment Goal

Trial Dates

May 2012 - December 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, 42096, Germany

Primary Outcome

AUC
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
Cmax
Maximum drug concentration in plasma after single dose administration
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
Cmax/C(24h)
Ratio of maximum drug concentration in plasma after single dose administration and drug concentration at 24 h post dosing
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No

Secondary Outcome

Cmax/D
Maximum drug concentration in plasma after single dose administration divided by dose (mg)
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
tmax
Time to reach maximum drug concentration in plasma after single (first) dose
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
t½
Half-life associated with the terminal slope
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
AUC/D
AUC divided by dose (mg)
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
Cmax/D
Maximum drug concentration in plasma after single dose administration divided by dose (mg)
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
CL/f
Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
AUC(0-tlast)
AUC from time 0 to the last data point
Time Frame:
Pre-dose and up to 72 h post administration
Safety Issue:
No
Number of participants with adverse events
Time Frame:
Approximately eight weeks
Safety Issue:
Yes

Trial design

Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4 days pre- and co-treatment with Antra® 2 x 20 mg OD, respectively, on the pharmacokinetics of a single dose of 5 mg BAY 1021189, taken as 4 x 1.25 mg IR tablets, in a threefold crossover, randomized, open label design in healthy male subjects

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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