check_circleStudy 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

  • - 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)

  • - 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
June 2014 - March 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42113, Germany

Primary Outcome

  • Number of Subjects with Treatment Emergent Adverse Events (TEAE) And Treatment Emergent Serious Adverse Event (TESAE)–Pilot Part
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Pre-dose (00h) up to day 2 after drug administration
  • Change From Baseline for Bleeding Time at 3 hour Post treatment - Main Part
    date_rangeTime Frame:
    Baseline, 3 hour Post treatment
  • Change From Baseline in Platelet Aggregation Time at 3hour Posttreatment With Vericiguat /Aspirin and Aspirin Alone - Main part
    date_rangeTime 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
4