check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15357
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Multiple Dose escalation Phase I study of BAY1021189
Trial purpose
The primary objective of this study was to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily 1.25, 5.0 and 10 mg and twice daily 5 mg of vericiguat administered orally as one or multiples of 1.25 mg IR-tablets over 7 days in 12 healthy male subjects (9 on active drug and 3 on placebo) per dose step.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
46Trial Dates
May 2012 - December 2013Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wuppertal, 42113, Germany |
Primary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Maximum Drug Plasma Concentration (Cmax) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Area Under the Plasma Concentration Versus Time Curve During any Dosing Interval After Multiple Doses (AUCtau,md) of Vericiguat in Plasma on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Maximum Drug Plasma Concentration During any Dosing Interval After Multiple Doses (Cmax,md) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Number of Subjects With Clinically Relevant Changes in Blood Pressure After Vericiguat Treatment in Comparison to Placebodate_rangeTime Frame:Baseline up to follow-up visit (10 days after last dose)
- Change From Baseline in Heart Rate Over 1 Minute at Days 1 and 7date_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Impedance Cardiographic Assessments at Days 1 and 7: Cardiac Outputdate_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Impedance Cardiographic Assessments at Days 1 and 7: Cardiac Indexdate_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Impedance Cardiographic Assessments at Days 1 and 7: Heart Ratedate_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Impedance Cardiographic Assessments at Days 1 and 7: Stroke Volumedate_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Impedance Cardiographic Assessments at Days 1 and 7: Systemic Vascular Resistancedate_rangeTime Frame:Baseline, Day 1 (start of Day 2) and Day 7 (start of Day 8)
- Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP) at Days 1 and 7date_rangeTime Frame:Baseline, Day 1 (start of Day 2: 0, 12 h), Day 7 (start of Day 8: 0, 12 h)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)date_rangeTime Frame:Baseline up to follow-up visit (10 days after last dose)
- Number of Subjects With Abnormal Clinical Laboratory Findingsdate_rangeTime Frame:Baseline up to follow-up visit (10 days after last dose)
- Number of Subjects With Clinically Relevant Findings in Electrocardiogram (ECG) Parametersdate_rangeTime Frame:Baseline up to follow-up visit (10 days after last dose)
Secondary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose (AUC[0tlast]/ D) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose per Kilogram Body Weight (AUC[0tlast] norm) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Maximum Drug Plasma Concentration Divided by Dose (Cmax/D) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Maximum Drug Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Half-life Associated With the Terminal Slope (t1/2) of Vericiguat in Plasma on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Time to Reach Maximum Drug Plasma Concentration (tmax) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Mean Residence Time (MRT) of Vericiguat in Plasma on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Amount of Drug Excreted via Urine (AE,ur[t1t2]) of Vericiguat on Day 1date_rangeTime Frame:0-48 h
- Renal Clearance (CLR) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Total Body Clearance of Drug from Plasma (CL/F) of Vericiguat on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of Vericiguat in Plasma on Day 1date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 1
- Ratio of Maximum Drug Concentration to Concentration at 24 Hours (Cmax/C24) for Once Daily Vericiguat Treatment on Day 1date_rangeTime Frame:0-24 h on Day 1
- Ratio of Maximum Drug Concentration to Concentration at 12 Hours (Cmax/C12) for Twice Daily Vericiguat Treatment on Day 1date_rangeTime Frame:0-12 h on Day 1
- AUC During any Dosing Interval After Multiple Doses Divided by Dose (AUCtau,md/D) of Vericiguat in Plasma on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- AUC During any Dosing Interval After Multiple Dose per Kilogram Body Weight (AUCtau,md,norm) of Vericiguat in Plasma on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Maximum Drug Plasma Concentration During any Dosing Interval After Multiple Doses Divided by Dose (Cmax,md/D) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Maximum Drug Plasma Concentration During any Dosing Interval After Multiple Doses per Kilogram Body Weight (Cmax,md,norm) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Time to Reach Maximum Drug Plasma Concentration After Multiple Doses (tmax,md) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Half-life Associated With the Terminal Slope (t1/2) of Vericiguat in Plasma on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Mean Residence Time (MRT) of Vericiguat in Plasma on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Percentage of Peak Trough Fluctuation (%PTF) on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Accumulation Ratio Calculated From Cmax After Multiple Dosing and Cmax After Single Dosing (RA,Cmax) on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Accumulation Ratio4 (RA4) on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Accumulation Ratio Calculated From AUCtau After Multiple Dosing and AUCtau After Single Dosing (RA,AUC) on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Amount of Drug Excreted via Urine (AE,ur[t1t2]) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Renal Clearance (CLR) of Vericiguat on Day 7date_rangeTime Frame:0-24 h (OD) and 0-12 h (BID) on Day 7
- Ratio of Maximum Drug Concentration to Concentration at 168 Hours After Multiple Doses (Cmax,md/C168) for Once Daily Vericiguat Treatment on Day 7date_rangeTime Frame:0-24 h on Day 7
- Ratio of Maximum Drug Concentration to Concentration at 156 Hours After Multiple Doses (Cmax,md/C156) for Twice Daily Vericiguat Treatment on Day 7date_rangeTime Frame:0-12 h on Day 7
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
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