check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15836
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Single and multiple dose escalation study in Japanese subjects
Trial purpose
The primary objective of this study is to
• Investigate the safety and tolerability of BAY1021189 after single and multiple doses of 1.25, 5, 7.5 and 10 mg in Japanese healthy male subjects
The secondary objectives are to
• Investigate the pharmacodynamics and pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
• Exploratorily investigate the influence of food intake on the pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
• Investigate the safety and tolerability of BAY1021189 after single and multiple doses of 1.25, 5, 7.5 and 10 mg in Japanese healthy male subjects
The secondary objectives are to
• Investigate the pharmacodynamics and pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
• Exploratorily investigate the influence of food intake on the pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
Key Participants Requirements
Sex
MaleAge
20 - 40 YearsTrial summary
Enrollment Goal
48Trial Dates
November 2012 - May 2013Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kagoshima, 890-0081, Japan |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to Day 15
- Vital signsdate_rangeTime Frame:Up to Day 11
- 12-lead electrocardiogram (ECG)date_rangeTime Frame:Up to Day 11
- Standing blood pressure proceduredate_rangeTime Frame:Up to Day 11
- Clinical laboratory testdate_rangeTime Frame:Up to Day 15
- AUCArea under the plasma concentration vs time curve from zero to infinity after single (first) dosedate_rangeTime Frame:Day 1 to Day 5
- AUC/DAUC divided by dose (mg)date_rangeTime Frame:Day 1 to Day 5
- AUCnormArea under the curve divided by dose per kg body weightdate_rangeTime Frame:Day 1 to Day 5
- AUC(0-24)AUC from time 0 to 24 hours after administrationdate_rangeTime Frame:Day 1 to Day 5
- AUC(0-24)/DAUC(0-24) by dose (mg)date_rangeTime Frame:Day 1 to Day 5
- AUC(0-24),normAUC(0-24) divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 1 to Day 5
- CmaxMaximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:Day 1 to Day 5
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)date_rangeTime Frame:Day 1 to Day 5
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 1 to Day 5
- AUC(0-24)AUC from time 0 to 24 hours after administrationdate_rangeTime Frame:Day 5 to Day 6
- AUC(0-24)/DAUC(0-24) by dose (mg)date_rangeTime Frame:Day 5 to Day 6
- AUC(0-24),normAUC(0-24) divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 5 to Day 6
- CmaxMaximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:Day 5 to Day 6
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)date_rangeTime Frame:Day 5 to Day 6
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 5 to Day 6
- tmaxTime to reach maximum drug concentration in plasma after single (first) dosedate_rangeTime Frame:Day 5 to Day 6
- AUCτ,ssAUC during any dosing interval at steady statedate_rangeTime Frame:Day 11 to Day 15
- AUCτ,ss/DAUCτ,ss divided by dose (mg)date_rangeTime Frame:Day 11 to Day 15
- AUCτ,ss, normAUCτ,ss divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 11 to Day 15
- Cmax,ssMaximum drug concentration in plasma at steady state during a dosage intervaldate_rangeTime Frame:Day 11 to Day 15
- Cmax,ss/DMaximum drug concentration in plasma at steady state divided by dose (mg)date_rangeTime Frame:Day 11 to Day 15
- Cmax,ss,normMaximum drug concentration in plasma at steady state during a dosage interval divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 11 to Day 15
Secondary Outcome
- AUC(0-tlast)AUC from time 0 to the last data pointdate_rangeTime Frame:Day 1 to Day 5
- AUC(0-tlast)/D)AUC(0-tlast) by dose (mg)date_rangeTime Frame:Day 1 to Day 5
- AUC(0 tlast),normAUC(0-tlast) divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 1 to Day 5
- tmaxTime to reach maximum drug concentration in plasma after single (first) dosedate_rangeTime Frame:Day 1 to Day 5
- t1/2Half-life associated with the terminal slopedate_rangeTime Frame:Day 1 to Day 5
- MRTMean residence timedate_rangeTime Frame:Day 1 to Day 5
- CL/FTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)date_rangeTime Frame:Day 1 to Day 5
- AE,urAmount of drug excreted via urinedate_rangeTime Frame:Day 1 to Day 5
- AE,ur(0-24)Amount of drug excreted into urine from 0 to 24 hours after administrationdate_rangeTime Frame:Day 1 to Day 5
- %AE,urRate of amount of drug excreted into urine to the administered dosedate_rangeTime Frame:Day 1 to Day 5
- %AE,ur(0-24)Rate of amount of drug excreted into urine from 0 to 24 hours afterdate_rangeTime Frame:Day 1 to Day 5
- CLRRenal body clearance of drugdate_rangeTime Frame:Day 1 to Day 5
- Vz/FApparent volume of distribution during terminal phase after oral administrationdate_rangeTime Frame:Day 1 to Day 5
- tmaxTime to reach maximum drug concentration in plasma after single (first) dosedate_rangeTime Frame:Day 11 to Day 15
- t1/2Half-life associated with the terminal slopedate_rangeTime Frame:Day 11 to Day 15
- MRTMean residence timedate_rangeTime Frame:Day 11 to Day 15
- CLss/FCL/F after steady statedate_rangeTime Frame:Day 11 to Day 15
- PTFPeak trough fluctuationdate_rangeTime Frame:Day 11 to Day 15
- AE,ur(0-24)Amount of drug excreted into urine from 0 to 24 hours after administrationdate_rangeTime Frame:Day 11 to Day 15
- %AE,ur(0-24)Rate of amount of drug excreted into urine from 0 to 24 hours after administration to the administered dosedate_rangeTime Frame:Day 11 to Day 15
- CLRRenal body clearance of drugdate_rangeTime Frame:Day 11 to Day 15
- Accumulation ratios: RACmax, RLIN and RAAUCdate_rangeTime Frame:Day 11 to Day 15
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
5