Trial Condition(s):
Clinical Pharmacology
Single dose escalation study of BAY1021189
Bayer Identifier:
15355
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
Primary objective: To investigate the safety and tolerability of BAY1021189 after single oral doses of 0.5 mg up to 20 mg administered as solution in healthy male subjects.
Secondary objectives: To investigate the pharmacodynamics and pharmacokinetics of BAY1021189.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria - Healthy young male subjects, 18 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2 - Clinically relevant changes/deviations from normal ECG, physical examination, clinical chemistry, hematology, urinalysis, and/or blood pressure, heart rate (vital signs) - Regular use of therapeutic or recreational drugs - Positive testing in drug or urine screening - Recent donation of blood/blood components - Subjects hypersensitive to the investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies - History of/current relevant diseases of vital or other organs and of the central nervous system and/or medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results - Regular daily consumption of an amount of beer, alcohol, xanthine-containing beverages, and/or cigarettes that may affect study results - Recent or current use of medication which could interfere with the investigational products - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination or effects of the study drug would not have been normal - Regular use of medicines - All types of tobacco smoking in the non-smoker groups within the last 4 weeks prior to study drug administration - Suspicion of drug or alcohol abuse - Special diets preventing the subject from eating the standard meals during the study - Intake of foods or beverages containing grapefruit within 1 week before study drug administration - Excluded therapies within 1 month before study drug administration - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immune deficiency virus antibodies (anti-HIV 1+2) - History of postural syncopes
Trial Summary
Enrollment Goal
69
Trial Dates
Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Wuppertal, Germany, 42096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single dose, single-blind, randomized, placebo-controlled dose escalation study to investigate safety, tolerability, pharmacokinetic, and pharmacodynamic properties of BAY 1021189 after oral dosing in 10 healthy male non-smoking subjects per dose step and 10 healthy male smoking subjects in one dose step in addition
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
9
Primary Outcome
- AUCArea under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single doseTimeframe: Pre-dose and up to 72 h post-dose
- AUC/DAUC divided by doseTimeframe: Pre-dose and up to 72 h post-dose
- CmaxMaximum total (bound and unbound) drug concentration in plasma after single dose administrationTimeframe: Pre-dose and up to 72 h post-dose
- Cmax/DCmax divided by doseTimeframe: Pre-dose and up to 72 h post-dose
Secondary Outcome
- Cmax,normCmax divided by dose per kg body weightTimeframe: Pre-dose and up to 72 h post-dose
- tmaxTime to reach Cmax (in case of 2 identical Cmax values, the first tmax was to be used)Timeframe: Pre-dose and up to 72 h post-dose
- t½Half-life associated with the terminal slopeTimeframe: Pre-dose and up to 72 h post-dose
- MRTMean residence timeTimeframe: Pre-dose and up to 72 h post-dose
- AUCnormAUC divided by dose per kg body weightTimeframe: Pre-dose and up to 72 h post-dose
- AUC(0-tlast)AUC from time 0 to the last data pointTimeframe: Pre-dose and up to 72 h post-dose
- AUC(0-tlast)normAUC(0-tlast) divided by dose per kg body weightTimeframe: Pre-dose and up to 72 h post-dose
- Vz/FApparent volume of distribution during terminal phase after extravascular administrationTimeframe: Pre-dose and up to 72 h post-dose
- AE,urAmount of drug excreted into urine, only calculated for dose steps where drug concentrations in urine were measuredTimeframe: Pre-dose and up to 72 h post-dose
- %AE,urPercent of drug excreted into urine, only calculated for dose steps where drug concentrations in urine were measuredTimeframe: Pre-dose and up to 72 h post-dose
- CLRRenal body clearance of drug only calculated for dose steps where drug concentrations in urine were measuredTimeframe: Pre-dose and up to 72 h post-dose
- CL/FTotal body clearance of drug calculated after extravascular administration (eg apparent oral clearance)Timeframe: Pre-dose and up to 72 h post-dose
- HRHeart rateTimeframe: Approximately 4 weeks
- HR over 1 minHeart rate over 1 minTimeframe: From 24 h prior to dosing and up to 24 h post-dose
- Standing BP procedureStanding blood pressure procedureTimeframe: From 22 h prior to dosing and up to 4 h post-dose
- Impedance cardiographyStroke volume, cardiac output, heart rate, cardiac index = cardiac output / body surface areaTimeframe: From 24 h prior to dosing and up to 24 post-dose
- Vasoactive hormonesPlasma renin activity, plasma angiotensin II, noradrenaline, adrenaline, and cyclic guanosine monophosphate as well as serum aldosteroneTimeframe: From 24 h prior to dosing and up to 48 h post-dose
- BiomarkersB-type natriuretic peptide (BNP), n-terminal prohormone of BNP, asymmetric dimethylarginine and osteopontinTimeframe: From 24 h prior to dosing and up to 24 h post-dose
- Number of participants with adverse eventsTimeframe: Approximately 4 weeks
- BPBlood pressureTimeframe: Approximately 4 weeks
Additional Information
Copyright © Bayer
Powered by
