Trial Condition(s):

Clinical Pharmacology

Relative bioavailability and food interaction study of BAY1021189

Bayer Identifier:

15356

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-004841-42

Study Completed

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.

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
16
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, 42113

Status
Completed
 

Trial Design