Trial Condition(s):

Clinical Pharmacology

Drug-drug interaction with aspirin

Bayer Identifier:

15838

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000765-52

Study Completed

Trial Purpose

Primary objective of pilot part:
• to investigate the safety and tolerability of a single dose of 15 mg vericiguat administered as three 5 mg immediate release (IR) tablets in fasted state.
Secondary objective of pilot part:
• to investigate the pharmacokinetics of a single dose of 15 mg vericiguat administered as three 5 mg IR tablets in fasted state.

Primary objective of main part:
• to investigate the influence of a combined treatment of a single dose of 10 mg or 15 mg vericiguat (administered as two or three 5 mg IR tablets) and Aspirin on bleeding time and platelet aggregation (pharmacodynamics).

Inclusion Criteria
- Healthy white male subjects
- 18 to 45 years (inclusive) of age
- Normal body weight with a body mass index (BMI) between 18 and 30 kg/m² (both inclusive)
Exclusion Criteria
- Subjects with conspicuous findings in medical history and at the screening visit
- Subjects with a medical disorder, condition or history of such that would have impaired the subject’s ability to participate or complete this study in the opinion of the investigator or the sponsor
- Febrile illness within 1 week before the first drug administration
- Subjects with hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents
- Regular use of therapeutic or recreational drugs
- Use of medication within the 2 weeks preceding the study which could have interfered with the investigational product
- Therapies (e.g. physiotherapy, acupuncture, etc.) within 4 weeks before starting study treatment
- Regular daily consumption of more than 10 cigarettes
- Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form

Trial Summary

Enrollment Goal
26
Trial Dates
black-arrow
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

Wuppertal, Germany, 42113

Status
Completed
 

Trial Design