Trial Condition(s):
Clinical Pharmacology
Single and multiple dose escalation study in Japanese subjects
Bayer Identifier:
15836
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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
Inclusion Criteria
- Japanese healthy male subjects - 20 to 40 years of age - 17.6 to 26.4 kg / m² of Body mass index (BMI)
Exclusion Criteria
- Subjects with conspicuous findings in medical history, and screening or Day 1 before the first study drug administration examination results - Subjects with diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Subjects with known hypersensitivity to the study drugs (active substances, or excipients of the preparations) - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies - Subjects with lactose intolerance - Subjects with relevant diseases within the last 4 weeks prior to the first study drug administration - Subjects with febrile illness within 1 week before the first study drug administration - Subjects with regular use of medicines - Subjects with regular use of therapeutic or recreational drugs
Trial Summary
Enrollment Goal
48
Trial Dates
Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Kagoshima, Japan, 890-0081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-center, randomized, single-blinded, placebo-controlled, group-comparison, combined single and multiple dose escalation study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 1021189 in Japanese healthy adult male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
5
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)Timeframe: Up to Day 15
- Vital signsTimeframe: Up to Day 11
- 12-lead electrocardiogram (ECG)Timeframe: Up to Day 11
- Standing blood pressure procedureTimeframe: Up to Day 11
- Clinical laboratory testTimeframe: Up to Day 15
- AUCArea under the plasma concentration vs time curve from zero to infinity after single (first) doseTimeframe: Day 1 to Day 5
- AUC/DAUC divided by dose (mg)Timeframe: Day 1 to Day 5
- AUCnormArea under the curve divided by dose per kg body weightTimeframe: Day 1 to Day 5
- AUC(0-24)AUC from time 0 to 24 hours after administrationTimeframe: Day 1 to Day 5
- AUC(0-24)/DAUC(0-24) by dose (mg)Timeframe: Day 1 to Day 5
- AUC(0-24),normAUC(0-24) divided by dose (mg) per kg body weightTimeframe: Day 1 to Day 5
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: Day 1 to Day 5
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)Timeframe: Day 1 to Day 5
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightTimeframe: Day 1 to Day 5
- AUC(0-24)AUC from time 0 to 24 hours after administrationTimeframe: Day 5 to Day 6
- AUC(0-24)/DAUC(0-24) by dose (mg)Timeframe: Day 5 to Day 6
- AUC(0-24),normAUC(0-24) divided by dose (mg) per kg body weightTimeframe: Day 5 to Day 6
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: Day 5 to Day 6
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg)Timeframe: Day 5 to Day 6
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightTimeframe: Day 5 to Day 6
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Day 5 to Day 6
- AUCτ,ssAUC during any dosing interval at steady stateTimeframe: Day 11 to Day 15
- AUCτ,ss/DAUCτ,ss divided by dose (mg)Timeframe: Day 11 to Day 15
- AUCτ,ss, normAUCτ,ss divided by dose (mg) per kg body weightTimeframe: Day 11 to Day 15
- Cmax,ssMaximum drug concentration in plasma at steady state during a dosage intervalTimeframe: Day 11 to Day 15
- Cmax,ss/DMaximum drug concentration in plasma at steady state divided by dose (mg)Timeframe: 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 weightTimeframe: Day 11 to Day 15
Secondary Outcome
- AUC(0-tlast)AUC from time 0 to the last data pointTimeframe: Day 1 to Day 5
- AUC(0-tlast)/D)AUC(0-tlast) by dose (mg)Timeframe: Day 1 to Day 5
- AUC(0 tlast),normAUC(0-tlast) divided by dose (mg) per kg body weightTimeframe: Day 1 to Day 5
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Day 1 to Day 5
- t1/2Half-life associated with the terminal slopeTimeframe: Day 1 to Day 5
- MRTMean residence timeTimeframe: Day 1 to Day 5
- CL/FTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Day 1 to Day 5
- AE,urAmount of drug excreted via urineTimeframe: Day 1 to Day 5
- AE,ur(0-24)Amount of drug excreted into urine from 0 to 24 hours after administrationTimeframe: Day 1 to Day 5
- %AE,urRate of amount of drug excreted into urine to the administered doseTimeframe: Day 1 to Day 5
- %AE,ur(0-24)Rate of amount of drug excreted into urine from 0 to 24 hours afterTimeframe: Day 1 to Day 5
- CLRRenal body clearance of drugTimeframe: Day 1 to Day 5
- Vz/FApparent volume of distribution during terminal phase after oral administrationTimeframe: Day 1 to Day 5
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Day 11 to Day 15
- t1/2Half-life associated with the terminal slopeTimeframe: Day 11 to Day 15
- MRTMean residence timeTimeframe: Day 11 to Day 15
- CLss/FCL/F after steady stateTimeframe: Day 11 to Day 15
- PTFPeak trough fluctuationTimeframe: Day 11 to Day 15
- AE,ur(0-24)Amount of drug excreted into urine from 0 to 24 hours after administrationTimeframe: 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 doseTimeframe: Day 11 to Day 15
- CLRRenal body clearance of drugTimeframe: Day 11 to Day 15
- Accumulation ratios: RACmax, RLIN and RAAUCTimeframe: Day 11 to Day 15
Additional Information
Not Available
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