Trial Condition(s):

Clinical Pharmacology

Multiple Dose escalation Phase I study of BAY1021189

Bayer Identifier:

15357 Identifier:

Not Available

EudraCT Number:


EU CT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study was to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily 1.25, 5.0 and 10 mg and twice daily 5 mg of vericiguat administered orally as one or multiples of 1.25 mg IR-tablets over 7 days in 12 healthy male subjects (9 on active drug and 3 on placebo) per dose step.

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 and below/equal 29.9 kg/m²
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be 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
- 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
Trial Dates
Could I receive a placebo?
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers

Where to Participate


Investigative Site

Wuppertal, Germany, 42113

Trial Design