Trial Condition(s):

Clinical Pharmacology

Single dose escalation study of BAY1021189

Bayer Identifier:

15355

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2011-001627-21

Study Completed

Trial Purpose

Primary objective: To investigate the safety and tolerability of BAY1021189 after single oral doses of 0.5 mg up to 20 mg administered as solution in healthy male subjects.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY1021189.

Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria
- Healthy young male subjects, 18 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2


- Clinically relevant changes/deviations from normal ECG, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs) 
- Regular use of therapeutic or recreational drugs 
- Positive testing in drug or urine screening 
- Recent donation of blood/blood components 
- Subjects hypersensitive to the investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies 
- History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results 
- Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results
- Recent or current use of medication which could interfere with the investigational products 
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination or effects of the study drug would not have been normal 
- Regular use of medicines 
- All types of tobacco smoking in the non-smoker groups within the last 4 weeks prior to study drug administration 
- Suspicion of drug or alcohol abuse 
- Special diets preventing the subject from eating the standard meals during the study - Intake of foods or beverages containing grapefruit within 1 week before study drug administration 
- Excluded therapies within 1 month before study drug administration 
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immune deficiency virus antibodies (anti-HIV 1+2) - History of postural syncopes

Trial Summary

Enrollment Goal
69
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
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