Trial Condition(s):

Heart Failure

Multiple dose food effect Phase I study of BAY1021189

Bayer Identifier:

16440

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-004839-23

Study Completed

Trial Purpose

The primary objective of this study was to investigate the PK of BAY 1021189 after single oral doses of 1.25 mg, 2.5 mg, 5 mg and 10 mg administered as IR tablets in the fed state (high-fat, high-calorie breakfast).

The secondary objective of this study was to assess safety and tolerability of BAY 1021189.

Inclusion Criteria
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first screening visit
- Ethnicity: White
- Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal
- Known hypersensitivity to the study drug (active substances or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Relevant diseases within the last 4 weeks prior to study drug administration
- Febrile illness within 1 week before study drug administration
- History of postural syncopes 
- Regular use of medicines
- Regular use of therapeutic or recreational drugs (eg carnitin products, anabolics, high dose vitamins)
- Use of medication within 2 weeks before study drug administration which could oppose the study objectives or which might influence them

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

Köln, Germany, 51063

Status
Completed
 

Trial Design