Study Completed

Clinical pharmacology

Bayer Identifier:

15838

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000765-52

EU CT Number:

Not Available

Drug-drug interaction with aspirin

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).

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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

Trial Dates

June 2014 - March 2015

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Wuppertal, 42113, Germany

Primary Outcome

Number of Subjects with Treatment Emergent Adverse Events (TEAE) And Treatment Emergent Serious Adverse Event (TESAE)–Pilot Part
Time Frame:
From start of study drug administration up to 2 weeks after last drug administration
Mean Change From Baseline in Systolic,Diastolic and Arterial Blood Pressure at Specified Time Points- Pilot Part
Time Frame:
From Pre-dose interval follows 0,1,1.5,2,3,4,12 hour, up to Day 2 of drug administration
Number of Subjects with Clinically Abnormal Findings in ECG-Pilot part
Time Frame:
Predose of (00h) up to day 2 after study drug administration
Number of Subjects With At Least One Laboratory Value Above 1.5 x upper limit of normal range(ULN)– Pilot Part
Time Frame:
Pre-dose (00h) up to day 2 after drug administration
Change From Baseline for Bleeding Time at 3 hour Post treatment - Main Part
Time Frame:
Baseline, 3 hour Post treatment
Change From Baseline in Platelet Aggregation Time at 3hour Posttreatment With Vericiguat /Aspirin and Aspirin Alone - Main part
Time Frame:
Baseline, 3hour post treatment

Trial design

Aspirin interaction study to investigate the influence of Aspirin (2x 500 mg, 500 mg once daily) combined with a single dose of 15 mg Vericiguat (BAY 1021189) on bleeding time and platelet aggregation in comparison to a single dose of 15 mg Vericiguat (BAY 1021189) alone and to 2 single doses of Aspirin in healthy male subjects in randomized, non-blinded, non-placebo-controlled 3-fold cross-over design (main- part), preceded by a pilot part to investigate safety, tolerability and pharmacokinetics of 15 mg Vericiguat (BAY 1021189) tablet in healthy male subjects in a non-randomized, non-blinded, non-controlled design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms