Trial Condition(s):

Clinical Pharmacology

BAY1021189, Omeprazol/Antacida Interaction Study

Bayer Identifier:

15811

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000932-25

Study Completed

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.

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
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42096

Status
Completed
 

Trial Design