check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15838
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
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).
• 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
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
26Trial Dates
June 2014 - March 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere 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 Partdate_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 Partdate_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 partdate_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 Partdate_rangeTime Frame:Pre-dose (00h) up to day 2 after drug administration
- Change From Baseline for Bleeding Time at 3 hour Post treatment - Main Partdate_rangeTime Frame:Baseline, 3 hour Post treatment
- Change From Baseline in Platelet Aggregation Time at 3hour Posttreatment With Vericiguat /Aspirin and Aspirin Alone - Main partdate_rangeTime Frame:Baseline, 3hour post treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
4