Trial Condition(s):

Clinical Pharmacology

Multiple Dose escalation Phase I study of BAY1021189

Bayer Identifier:

15357

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-000953-30

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
46
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, 42113

Status
Completed
 

Trial Design