Trial Condition(s):

Heart Failure

Relative bioavailability and food effect study of two new 15 mg vericiguat formulations

Bayer Identifier:

19699

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2018-003651-38

Study Completed

Trial Purpose

The primary objectives of the pilot part were to
• investigate the safety and tolerability of a single dose of 15 mg vericiguat administered as tablets (loose combination of 10 mg+5 mg IR tablets) under fed conditions.

The primary objectives of the main part were to
• investigate the pharmacokinetics (PK) of vericiguat after oral administration of a single dose of 15 mg of two different formulations compared to a loose combination of 10 mg+5 mg IR tablets under fed conditions,
• investigate the PK of vericiguat after oral administration of a single dose of 15 mg of two different formulations under fed and fasted conditions.

The secondary objectives of the main part were
• safety and tolerability of vericiguat.

Inclusion Criteria
- Healthy male subjects aged 18 to 45 years (inclusive) and with a body mass index above or equal to 18.5 kg/m² and below or equal to 29.9 kg/m² at the first screening visit.
Exclusion Criteria
-  Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal.
- Known hypersensitivity to the study drugs (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 the first 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 the first study drug.
- Medical disorder that was considered to impair 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), for composition of the American breakfast.

Trial Summary

Enrollment Goal
36
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mannheim, Germany, 68167

Status
Completed
 

Trial Design