check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15356
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Relative bioavailability and food interaction study of BAY1021189
Trial purpose
Primary objectives:
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
Secondary objectives:
- Safety, tolerability and pharmacodynamics of BAY 1021189.
- Pharmacokinetics of BAY 1021189 after single oral doses of 1.25 mg and 5 mg immediate release tablets in comparison to 5 mg administered as oral solution
- Influence of food (high-fat, high-calorie breakfast) on the pharmacokinetics of BAY 1021189 after single oral administration of a 5 mg IR tablet.
Secondary objectives:
- Safety, tolerability and pharmacodynamics of BAY 1021189.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
16Trial Dates
December 2011 - June 2012Phase
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 participants with adverse eventsdate_rangeTime Frame:Approximately 8 weeksenhanced_encryptionYesSafety Issue:
- BPBlood pressuredate_rangeTime Frame:Approximately 8 weeksenhanced_encryptionYesSafety Issue:
- HR over 1 minHeart rate over 1 mindate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
- Plasma cGMPPlasma cyclic guanosine monophosphatedate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
- Impedance cardiographyThe following variables were measured: stroke volume, cardiac output, heart rate, cardiac indexdate_rangeTime Frame:Pre-dose and up to 8 h post-doseenhanced_encryptionNoSafety Issue:
- HRHeart ratedate_rangeTime Frame:Approximately 8 weeksenhanced_encryptionYesSafety Issue:
- AUCArea under the plasma concentration vs time curve from zero to infinity after single dosedate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- AUC/DAUC divided by dose (mg)date_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)date_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- CmaxMaximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUCnormArea under the curve divided by dose per kg body weightdate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightdate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- tmaxTime to reach maximum drug concentration in plasma after single dosedate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- t½Half-life associated with the terminal slopedate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- CL/FTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)date_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Vz/FApparent volume of distribution during terminal phase after oral administrationdate_rangeTime Frame:From pre-dose up to 72 h post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
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