Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction with aspirin
Bayer Identifier:
15838
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Wuppertal, Germany, 42113 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of Subjects with Treatment Emergent Adverse Events (TEAE) And Treatment Emergent Serious Adverse Event (TESAE)–Pilot PartTimeframe: 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 PartTimeframe: 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 partTimeframe: 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 PartTimeframe: Pre-dose (00h) up to day 2 after drug administration
- Change From Baseline for Bleeding Time at 3 hour Post treatment - Main PartTimeframe: Baseline, 3 hour Post treatment
- Change From Baseline in Platelet Aggregation Time at 3hour Posttreatment With Vericiguat /Aspirin and Aspirin Alone - Main partTimeframe: Baseline, 3hour post treatment
Additional Information
Not Available
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