Trial Condition(s):

Clinical Pharmacology

Pivotal food effect and dose proportionality study with 2.5 mg, 5 mg and 10 mg vericiguat IR tablets

Bayer Identifier:

18580

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-000980-18

EU CT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study was to
• investigate the PK dose proportionality of single oral doses of 2.5 mg and 5 mg vericiguat tablet in comparison to 10 mg vericiguat tablet in fed condition
• investigate the effect of a high fat, high calorie meal on the PK of vericiguat after a single oral dose of the 10 mg tablet in comparison to the 10 mg tablet in fasted state

The secondary objectives of this study were to assess the
• safety and tolerability of vericiguat

Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age (inclusive), BMI ≥18.0 and ≤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
- Febrile illness within 1 week prior to study drug administration
- History of postural syncopes
- A history of relevant diseases of vital organs, of the central nervous system or other organs
- Relevant diseases within the last 4 weeks prior to study drug administration
- Medical disorder that would have impaired the subject’s ability to complete the study in the opinion of the investigator.
- Known hypersensitivity to components of the American breakfast (high fat, high calorie breakfast)

Trial Summary

Enrollment Goal
30
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

Berlin, Germany, 13353

Status
Completed

Trial Design